Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 31, 2019 | |
Cover [Abstract] | ||
Entity Registrant Name | IONIS PHARMACEUTICALS INC | |
Entity Central Index Key | 0000874015 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 140,663,254 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 000-19125 | |
Entity Tax Identification Number | 33-0336973 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 2855 Gazelle Court | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92010 | |
City Area Code | 760 | |
Local Phone Number | 931-9200 | |
Title of 12(b) Security | Common Stock, $.001 Par Value | |
Trading Symbol | IONS | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 247,939 | $ 278,820 |
Short-term investments | 1,972,891 | 1,805,252 |
Contracts receivable | 49,077 | 12,759 |
Inventories | 19,375 | 8,582 |
Other current assets | 118,809 | 102,473 |
Total current assets | 2,408,091 | 2,207,886 |
Property, plant and equipment, net | 148,717 | 132,160 |
Patents, net | 26,985 | 24,032 |
Long-term deferred tax assets | 284,997 | 290,796 |
Deposits and other assets | 26,199 | 12,910 |
Total assets | 2,894,989 | 2,667,784 |
Current liabilities: | ||
Accounts payable | 13,146 | 28,660 |
Accrued compensation | 24,404 | 29,268 |
Accrued liabilities | 52,615 | 47,503 |
Income taxes payable | 1,945 | 858 |
Current portion of long-term obligations | 2,060 | 13,749 |
Current portion of deferred contract revenue | 137,607 | 160,256 |
Total current liabilities | 231,777 | 280,294 |
Long-term deferred contract revenue | 492,979 | 567,359 |
1 percent convertible senior notes | 596,355 | 568,215 |
Long-term obligations, less current portion | 16,016 | 4,914 |
Long-term mortgage debt | 59,896 | 59,842 |
Total liabilities | 1,397,023 | 1,480,624 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 300,000,000 shares authorized, 140,636,397 and 137,928,828 shares issued and outstanding at September 30, 2019 (unaudited) and December 31, 2018, respectively | 141 | 138 |
Additional paid-in capital | 2,219,090 | 2,047,250 |
Accumulated other comprehensive loss | (25,375) | (32,016) |
Accumulated deficit | (857,563) | (967,293) |
Total Ionis stockholders' equity | 1,336,293 | 1,048,079 |
Noncontrolling interest in Akcea Therapeutics, Inc. | 161,673 | 139,081 |
Total stockholders' equity | 1,497,966 | 1,187,160 |
Total liabilities and stockholders' equity | $ 2,894,989 | $ 2,667,784 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Stockholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 140,636,397 | 137,928,828 |
Common stock, shares outstanding (in shares) | 140,636,397 | 137,928,828 |
1 Percent Convertible Senior Notes [Member] | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Interest rate on convertible senior notes | 1.00% | 1.00% |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue: | ||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 |
Expenses: | ||||
Cost of products sold | 967 | 0 | 3,373 | 0 |
Research, development and patent | 104,366 | 95,255 | 316,948 | 301,153 |
Selling, general and administrative | 60,036 | 68,712 | 203,368 | 178,563 |
Total operating expenses | 165,369 | 163,967 | 523,689 | 479,716 |
Income (loss) from operations | 2,523 | (18,572) | 105,229 | (72,157) |
Other income (expense): | ||||
Investment income | 13,136 | 9,963 | 39,015 | 18,711 |
Interest expense | (12,002) | (11,282) | (35,404) | (33,332) |
Other income (expenses) | (140) | (22) | (332) | (145) |
Income (loss) before income tax (expense) benefit | 3,517 | (19,913) | 108,508 | (86,923) |
Income tax (expense) benefit | 14,915 | (452) | (9,204) | (824) |
Net income (loss) | 18,432 | (20,365) | 99,304 | (87,747) |
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. | 7,732 | 15,806 | 10,426 | 41,412 |
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ 26,163 | $ (4,559) | $ 109,730 | $ (46,335) |
Basic net income (loss) per share (in dollars per share) | $ 0.19 | $ (0.03) | $ 0.81 | $ (0.33) |
Shares used in computing basic net income (loss) per share (in shares) | 140,551 | 137,346 | 139,800 | 130,507 |
Diluted net income (loss) per share (in dollars per share) | $ 0.18 | $ (0.03) | $ 0.79 | $ (0.33) |
Shares used in computing diluted net income (loss) per share (in shares) | 143,408 | 137,346 | 142,821 | 130,507 |
Commercial Revenue [Member] | ||||
Revenue: | ||||
Revenue | $ 95,699 | $ 82,756 | $ 252,085 | $ 181,975 |
SPINRAZA Royalties [Member] | ||||
Revenue: | ||||
Revenue | 81,672 | 70,010 | 211,884 | 167,743 |
Product Sales, Net [Member] | ||||
Revenue: | ||||
Revenue | 11,945 | 0 | 28,563 | 0 |
Licensing and Other Royalty Revenue [Member] | ||||
Revenue: | ||||
Revenue | 2,082 | 12,746 | 11,638 | 14,232 |
Research and Development Revenue Under Collaborative Agreements [Member] | ||||
Revenue: | ||||
Revenue | $ 72,193 | $ 62,639 | $ 376,833 | $ 225,584 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) [Abstract] | ||||
Net income (loss) | $ 18,432 | $ (20,365) | $ 99,304 | $ (87,747) |
Unrealized gains (losses) on debt securities, net of tax | (1,110) | 133 | 6,666 | (834) |
Currency translation adjustment | (13) | (31) | (25) | 61 |
Comprehensive income (loss) | 17,309 | (20,263) | 105,945 | (88,520) |
Comprehensive loss attributable to noncontrolling interests | (7,729) | (13,943) | (10,423) | (38,005) |
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders | $ 25,038 | $ (6,320) | $ 116,368 | $ (50,515) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Total Ionis Stockholders' Equity [Member] | Noncontrolling Interest in Akcea Therapeutics, Inc. [Member] | Total |
Balance at Dec. 31, 2017 | $ 125 | $ 1,553,681 | $ (31,759) | $ (1,241,034) | $ 281,013 | $ 84,267 | $ 365,280 |
Balance (in shares) at Dec. 31, 2017 | 124,976 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ 0 | 0 | 0 | (46,335) | (46,335) | 0 | (46,335) |
Change in unrealized gains (losses), net of tax | 0 | 0 | (834) | 0 | (834) | 0 | (834) |
Foreign currency translation | 0 | 0 | 61 | 0 | 61 | 0 | 61 |
Biogen stock purchase | $ 11 | 447,954 | 0 | 0 | 447,965 | 0 | 447,965 |
Biogen stock purchase (in shares) | 11,502 | ||||||
Issuance of common stock in connection with employee stock plans | $ 2 | 14,800 | 0 | 0 | 14,802 | 0 | 14,802 |
Issuance of common stock in connection with employee stock plans (in shares) | 1,029 | ||||||
Stock-based compensation expense | $ 0 | 97,210 | 0 | 0 | 97,210 | 0 | 97,210 |
Noncontrolling interest in Akcea Therapetuics, Inc. | 0 | (83,332) | 0 | 0 | (83,332) | 45,327 | (38,005) |
Balance at Sep. 30, 2018 | $ 138 | 2,030,313 | (32,532) | (1,287,369) | 710,550 | 129,594 | 840,144 |
Balance (in shares) at Sep. 30, 2018 | 137,507 | ||||||
Balance at Jun. 30, 2018 | $ 137 | 2,011,561 | (32,634) | (1,282,810) | 696,254 | 121,181 | 817,436 |
Balance (in shares) at Jun. 30, 2018 | 137,157 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ 0 | 0 | 0 | (4,559) | (4,559) | 0 | (4,559) |
Change in unrealized gains (losses), net of tax | 0 | 0 | 133 | 0 | 133 | 0 | 133 |
Foreign currency translation | 0 | 0 | (31) | 0 | (31) | 0 | (31) |
Issuance of common stock in connection with employee stock plans | $ 1 | 6,225 | 0 | 0 | 6,226 | 0 | 6,226 |
Issuance of common stock in connection with employee stock plans (in shares) | 350 | ||||||
Stock-based compensation expense | $ 0 | 34,883 | 0 | 0 | 34,883 | 0 | 34,883 |
Noncontrolling interest in Akcea Therapetuics, Inc. | 0 | (22,356) | 0 | 0 | (22,356) | 8,413 | (13,943) |
Balance at Sep. 30, 2018 | $ 138 | 2,030,313 | (32,532) | (1,287,369) | 710,550 | 129,594 | 840,144 |
Balance (in shares) at Sep. 30, 2018 | 137,507 | ||||||
Balance at Dec. 31, 2018 | $ 138 | 2,047,250 | (32,016) | (967,293) | 1,048,079 | 139,081 | 1,187,160 |
Balance (in shares) at Dec. 31, 2018 | 137,929 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ 0 | 0 | 0 | 109,730 | 109,730 | 0 | 109,730 |
Change in unrealized gains (losses), net of tax | 0 | 0 | 6,666 | 0 | 6,666 | 0 | 6,666 |
Foreign currency translation | 0 | 0 | (25) | 0 | (25) | 0 | (25) |
Issuance of common stock in connection with employee stock plans | $ 3 | 112,132 | 0 | 0 | 112,135 | 0 | 112,135 |
Issuance of common stock in connection with employee stock plans (in shares) | 2,855 | ||||||
Stock-based compensation expense | $ 0 | 111,564 | 0 | 0 | 111,564 | 0 | 111,564 |
Payments of tax withholdings related to vesting of share-based awards and exercise of employee stock options | $ 0 | (18,841) | 0 | 0 | (18,841) | 0 | (18,841) |
Payments of tax withholdings related to vesting of share-based awards and exercise of employee stock options (in shares) | (147) | ||||||
Noncontrolling interest in Akcea Therapetuics, Inc. | $ 0 | (33,015) | 0 | 0 | (33,015) | 22,592 | (10,423) |
Balance at Sep. 30, 2019 | $ 141 | 2,219,090 | (25,375) | (857,563) | 1,336,293 | 161,673 | 1,497,966 |
Balance (in shares) at Sep. 30, 2019 | 140,637 | ||||||
Balance at Jun. 30, 2019 | $ 140 | 2,177,222 | (24,252) | (883,726) | 1,269,384 | 187,818 | 1,457,202 |
Balance (in shares) at Jun. 30, 2019 | 140,393 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ 0 | 0 | 0 | 26,163 | 26,163 | 0 | 26,163 |
Change in unrealized gains (losses), net of tax | 0 | 0 | (1,110) | 0 | (1,110) | 0 | (1,110) |
Foreign currency translation | 0 | 0 | (13) | 0 | (13) | 0 | (13) |
Issuance of common stock in connection with employee stock plans | $ 1 | 10,130 | 0 | 0 | 10,131 | 0 | 10,131 |
Issuance of common stock in connection with employee stock plans (in shares) | 255 | ||||||
Stock-based compensation expense | $ 0 | 24,126 | 0 | 0 | 24,126 | 0 | 24,126 |
Payments of tax withholdings related to vesting of share-based awards and exercise of employee stock options | $ 0 | (10,804) | 0 | 0 | (10,804) | 0 | (10,804) |
Payments of tax withholdings related to vesting of share-based awards and exercise of employee stock options (in shares) | (11) | ||||||
Noncontrolling interest in Akcea Therapetuics, Inc. | $ 0 | 18,416 | 0 | 0 | 18,416 | (26,145) | (7,729) |
Balance at Sep. 30, 2019 | $ 141 | $ 2,219,090 | $ (25,375) | $ (857,563) | $ 1,336,293 | $ 161,673 | $ 1,497,966 |
Balance (in shares) at Sep. 30, 2019 | 140,637 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net income (loss) | $ 99,304 | $ (87,747) |
Adjustments to reconcile net loss to net cash provided by operating activities: | ||
Depreciation | 9,345 | 7,650 |
Amortization of right-of-use operating lease assets | 1,433 | 0 |
Amortization of patents | 1,139 | 1,356 |
Amortization of premium (discount) on investments, net | (7,064) | 791 |
Amortization of debt issuance costs | 1,448 | 1,343 |
Amortization of convertible senior notes discount | 26,747 | 24,781 |
Stock-based compensation expense | 111,564 | 97,210 |
Non-cash losses related to patents, licensing and property, plant and equipment | 216 | 482 |
Provision for deferred income taxes | 4,103 | 0 |
Changes in operating assets and liabilities: | ||
Contracts receivable | (33,716) | 48,223 |
Inventories | (6,606) | 1,604 |
Other current and long-term assets | (23,377) | (26,573) |
Accounts payable | (18,764) | (13,606) |
Accrued compensation | (4,864) | (892) |
Accrued liabilities and deferred rent | 3,909 | (14,392) |
Deferred contract revenue | (97,029) | 447,168 |
Net cash provided by operating activities | 67,788 | 487,398 |
Investing activities: | ||
Purchases of short-term investments | (1,617,726) | (1,156,335) |
Proceeds from short-term investments | 1,465,600 | 568,517 |
Purchases of property, plant and equipment | (23,143) | (12,221) |
Acquisition of licenses and other assets, net | (4,196) | (3,317) |
Net cash used in investing activities | (179,465) | (603,356) |
Financing activities: | ||
Proceeds from equity awards | 112,137 | 18,254 |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | (18,841) | 0 |
Proceeds from the issuance of common stock to Biogen | 0 | 447,965 |
Principal payments on debt obligations | (12,500) | 0 |
Net cash provided by financing activities | 80,796 | 466,219 |
Net increase in cash and cash equivalents | (30,881) | 350,261 |
Cash and cash equivalents at beginning of period | 278,820 | 129,630 |
Cash and cash equivalents at end of period | 247,939 | 479,891 |
Supplemental disclosures of cash flow information: | ||
Interest paid | 5,474 | 5,434 |
Income taxes paid | 9,037 | 0 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Right-of-use assets obtained in exchange for lease obligations | 14,178 | 0 |
Amounts accrued for capital and patent expenditures | 3,251 | 2,296 |
Purchases of property, plant and equipment included in long-term obligations | $ 0 | $ 3,596 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 1. Basis of Presentation We prepared the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2019 and 2018 on the same basis as the audited financial statements for the year ended December 31, 2018. We included all normal recurring adjustments in the financial statements, which we considered necessary for a fair presentation of our financial position at such dates and our operating results and cash flows for those periods. Results for the interim periods are not necessarily indicative of the results for the entire year. For more complete financial information, these financial statements, and notes thereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2018 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC. In the condensed consolidated financial statements, we included the accounts of Ionis Pharmaceuticals, Inc. and the consolidated results of our majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries. We formed Akcea in December 2014. initial public offering, or IPO, Rx. Rx Refer to the section titled “Noncontrolling Interest in Akcea” in Note 2, Significant Accounting Policies, for further information related to our accounting for our investment in Akcea. Unless the context requires otherwise, “Ionis”, “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals, Inc. and its majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Significant Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Revenue Recognition Our Revenue Sources We generally recognize revenue when we have satisfied all contractual obligations and are reasonably assured of collecting the resulting receivable. We are often entitled to bill our customers and receive payment from our customers in advance of recognizing the revenue. In the instances in which we have received payment from our customers in advance of recognizing revenue, we include the amounts in deferred revenue on our consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Commercial Revenue: Product sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 and we added product sales from WAYLIVRA to our commercial revenue in the third quarter of 2019. Research and development revenue under collaborative agreements We often enter into collaboration agreements to license and sell our technology on an exclusive or non-exclusive basis. Our collaboration agreements typically contain multiple elements, or performance obligations, including technology licenses or options to obtain technology licenses, research and development, or R&D, services, and manufacturing services. We provide details about our collaboration agreements in Note 7, Collaborative Arrangements and Licensing Agreements, in our Annual Report on Form 10-K for the year ended December 31, 2018 . Under each collaboration note we discuss our specific revenue recognition conclusions, including our significant performance obligations under each collaboration. Steps to Recognize Revenue We use a five-step process to determine the amount of revenue we should recognize and when we should recognize it. The five step process is as follows: 1. Identify the contract Accounting rules require us to first determine if we have a contract with our partner, including confirming that we have met each of the following criteria: ● We and our partner approved the contract and we are both committed to perform our obligations; ● We have identified our rights, our partner’s rights and the payment terms; ● We have concluded that the contract has commercial substance, meaning that the risk, timing, or amount of our future cash flows is expected to change as a result of the contract; and ● We believe collectability is probable. 2. Identify the performance obligations We next identify the distinct goods and services we are required to provide under the contract. Accounting rules refer to these as our performance obligations. We typically have only one performance obligation at the inception of a contract, which is to perform R&D services. Often times we enter into a collaboration agreement in which we provide our partner with an option to license a medicine in the future. We may also provide our partner with an option to request that we provide additional goods or services in the future, such as active pharmaceutical ingredient, or API. We evaluate whether these options are material rights at the inception of the agreement. If we determine an option is a material right, we will consider the option a separate performance obligation. Historically, we have concluded that the options we grant to license a medicine in the future or to provide additional goods and services as requested by our partner are not material rights. These items are contingent upon future events that may not occur. When a partner exercises its option to license a medicine or requests additional goods or services, then we identify a new performance obligation for that item. In some cases, we deliver a license at the start of an agreement. If we determine that our partner has full use of the license and we do not have any additional material performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation. 3. Determine the transaction price We then determine the transaction price by reviewing the amount of consideration we are eligible to earn under the collaboration agreement, including any variable consideration. Under our collaboration agreements, consideration typically includes fixed consideration in the form of an upfront payment and variable consideration in the form of potential milestone payments, license fees and royalties. At the start of an agreement, our transaction price usually consists of only the upfront payment. We do not typically include any payments we may receive in the future in our initial transaction price because the payments are not probable and are contingent on certain events. We reassess the total transaction price at each reporting period to determine if we should include additional payments in the transaction price. Milestone payments are our most common type of variable consideration. We recognize milestone payments using the most likely amount method because we will either receive the milestone payment or we will not, which makes the potential milestone payment a binary event. The most likely amount method requires us to determine the likelihood of earning the milestone payment. We include a milestone payment in the transaction price once it is probable we will achieve the milestone event. Most often, we do not consider our milestone payments probable until we or our partner achieve the milestone event because the majority of our milestone payments are contingent upon events that are not within our control and are usually based on scientific progress. For example, in the first quarter of 2019, we earned $35 million in milestone payments from Roche when Roche dosed the first patient in the Phase 3 study of IONIS-HTT Rx 4. Allocate the transaction price Next, we allocate the transaction price to each of our performance obligations. When we have to allocate the transaction price to more than one performance obligation, we make estimates of the relative stand-alone selling price of each performance obligation because we do not typically sell our goods or services on a stand-alone basis. We then allocate the transaction price to each performance obligation based on the relative stand-alone selling price. We may engage a third party, independent valuation specialist to assist us with determining a stand-alone selling price for collaborations in which we deliver a license at the start of an agreement. We estimate the stand-alone selling price of these licenses using valuation methodologies, such as the relief from royalty method. Under this method, we estimate the amount of income, net of taxes, for the license. We then discount the projected income to present value. The significant inputs we use to determine the projected income of a license could include: ● Estimated future product sales; ● Estimated royalties on future product sales; ● Contractual milestone payments; ● Expenses we expect to incur; ● Income taxes; and ● A discount rate. We typically estimate the selling price of R&D services by using our internal estimates of the cost to perform the specific services. The significant inputs we use to determine the selling price of our R&D services include: ● The number of internal hours we estimate we will spend performing these services; ● The estimated cost of work we will perform; ● The estimated cost of work that we will contract with third parties to perform; and ● The estimated cost of API we will use. For purposes of determining the stand-alone selling price of the R&D services we perform and the API we will deliver, accounting guidance requires us to include a markup for a reasonable profit margin. We do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices. 5. Recognize revenue We recognize revenue in one of two ways, over time or at a point in time. We recognize revenue over time when we are executing on our performance obligation over time and our partner receives benefit over time. For example, we recognize revenue over time when we provide R&D services. We recognize revenue at a point in time when our partner receives full use of an item at a specific point in time. For example, we recognize revenue at a point in time when we deliver a license or API to a partner. For R&D services that we recognize over time, we measure our progress using an input method. The input methods we use are based on the effort we expend or costs we incur toward the satisfaction of our performance obligation. We estimate the amount of effort we expend, including the time we estimate it will take us to complete the activities, or costs we incur in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This results in a percentage that we multiply by the transaction price to determine the amount of revenue we recognize each period. This approach requires us to make numerous estimates and use significant judgement. If our estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that we recognize in the current and future periods. For example, 2013 Strategic Neurology collaboration with Biogen significant portion of the research and development services. We expect to complete the remainder of our services in 2020. As a result of our change in estimate, in the third quarter of 2019, we recorded a cumulative catch up adjustment of $ million to decrease revenue. We expect to complete the remainder of our services in 2020. Refer to Note 7, Collaborative Arrangements and Licensing Agreements , for further discussion of the cumulative catch up adjustment we made. The following are examples of when we typically recognize revenue based on the types of payments we receive. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We recognize royalty revenue in the period in which the counterparty sells the related product, which in certain cases may require us to estimate our royalty revenue. Commercial Revenue: Product sales, net We recognize product sales in the period Reserves for Product sales We record product sales at our net sales price, or transaction price. We include in our transaction price estimated reserves for discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that we offer within contracts between us and our customers, wholesalers, health care providers and other indirect customers. We estimate our reserves using the amounts we have earned or what we can claim on the associated sales. We classify our reserves as a reduction of accounts receivable when we are not required to make a payment or as a current liability when we are required to make a payment. In certain cases, our estimates include a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, our reserves reflect our best estimates under the terms of our respective contracts. When calculating our reserves and related product sales, we only recognize amounts to the extent that we consider it probable that we would not have to reverse in a future period a significant amount of the cumulative sales we previously recognized. The actual amounts we receive may ultimately differ from our reserve estimates. If actual amounts in the future vary from our estimates, we will adjust these estimates, which would affect our net product sales in the respective period. The following are the components of variable consideration related to product sales: Chargebacks: Government rebates : We are subject t Trade discounts: Distribution services Product returns: Other incentives: Research and development revenue under collaboration agreements: Upfront payments When we enter into a collaboration agreement with an upfront payment, we typically record the entire upfront payment as deferred revenue if our only performance obligation is for R&D services we will provide in the future. We amortize the upfront payment into revenue as we perform the R&D services. For example, under our collaboration agreement with Roche to develop IONIS-FB-L Rx for the treatment of complement-mediated diseases Milestone payments We are required to include additional consideration in the transaction price when it is probable. We typically include milestone payments for R&D services in the transaction price when they are achieved. We include these milestone payments when they are achieved because there is considerable uncertainty in the research and development processes that trigger these payments under our collaboration agreements. Similarly, we include approval milestone payments in the transaction price once the medicine is approved by the applicable regulatory agency. We will recognize sales-based milestone payments in the period in which we achieve the milestone under the sales-based royalty exception allowed under accounting rules. We recognize milestone payments that relate to an ongoing performance obligation over our period of performance. For example, in the second quarter of 2019, we achieved a $7.5 million milestone payment from Biogen when we advanced a new target for an unidentified neurological disease under our 2018 strategic neurology collaboration. We added this payment to the transaction price and allocated it to our R&D services performance obligation. We are recognizing revenue related to this milestone payment over our estimated period of performance. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event and we do not have a performance obligation. For example, in the third quarter of 2019, we recognized an $8 million milestone payment when Biogen initiated a Phase 1/2 study of IONIS-LRRK2 Rx (BIIB094) for the treatment of people with Parkinson’s disease We concluded that the milestone payment was not related to our R&D services performance obligation. Therefore, we recognized the milestone payment in full in the third quarter of 2019. License fees We generally recognize as revenue the total amount we determine to be the stand-alone selling price of a license when we deliver the license to our partner. This is because our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery. Sublicense fees We recognize sublicense fee revenue in the period in which a party, who has already licensed our technology, further licenses the technology to another party because we do not have any performance obligations related to the sublicense. Amendments to agreements From time to time we amend our collaboration agreements. When this occurs, we are required to assess the following items to determine the accounting for the amendment: 1) If the additional goods and/or services are distinct from the other performance obligations in the original agreement; and 2) If the goods and/or services are at a stand-alone selling price. If we conclude the goods and/or services in the amendment are distinct from the performance obligations in the original agreement and at a stand-alone selling price, we account for the amendment as a separate agreement. If we conclude the goods and/or services are not distinct and at their stand-alone selling price, we then assess whether the remaining goods or services are distinct from those already provided. If the goods and/or services are distinct from what we have already provided, then we allocate the remaining transaction price from the original agreement and the additional transaction price from the amendment to the remaining goods and/or services. If the goods and/or services are not distinct from what we have already provided, we update the transaction price for our single performance obligation and recognize any change in our estimated revenue as a cumulative adjustment. For example, in May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize IONIS-FXI Rx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $ million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXI Rx in people with end-stage renal disease on hemodialysis and for providing an initial supply of API. In February 2017, we amended our agreement with Bayer to advance IONIS-FXI Rx and to initiate development of IONIS-FXI-L Rx , which Bayer licensed. As part of the 2017 amendment, Bayer paid us $ million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXI Rx and IONIS-FXI-L Rx . Under the 2017 amendment, we concluded we had a new agreement with performance obligations. These performance obligations were to deliver the license of IONIS-FXI-L Rx , to provide R&D services and to deliver API. We allocated the $ million transaction price to these performance obligations. Note 7, Collaborative Arrangements and Licensing Agreements of our accounting treatment for our Bayer collaboration. Multiple agreements From time to time, we may enter into separate agreements at or near the same time with the same partner. We evaluate such agreements to determine whether we should account for them individually as distinct arrangements or whether the separate agreements should be combined and accounted for together. We evaluate the following to determine the accounting for the agreements: ● Whether the agreements were negotiated together with a single objective; ● Whether the amount of consideration in one contract depends on the price or performance of the other agreement; or ● Whether the goods and/or services promised under the agreements are a single performance obligation. Our evaluation involves significant judgment to determine whether a group of agreements might be so closely related that accounting guidance requires us to account for them as a combined arrangement. For example, in the second quarter of 2018, we entered into two separate agreements with Biogen at the same time: a new strategic neurology collaboration agreement and a stock purchase agreement, or SPA. We evaluated the Biogen agreements to determine whether we should treat the agreements separately or combine them. We considered that the agreements were negotiated concurrently and in contemplation of one another. Based on these facts and circumstances, we concluded that we should evaluate the provisions of the agreements on a combined basis. Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners or customers and that are due to us unconditionally for goods we have delivered or services we have performed. When we bill our partners or customers with payment terms based on the passage of time, we consider the contract receivable to be unconditional. We typically receive payment within one quarter of billing our partner or customer Unbilled SPINRAZA Royalties Our unbilled SPINRAZA royalties represent our right to receive consideration from Biogen in advance of when we are eligible to bill Biogen for SPINRAZA royalties. We include these unbilled amounts in other current assets on our condensed consolidated balance sheet. Deferred Revenue We are often entitled to bill our customers and receive payment from our customers in advance of our obligation to provide services or transfer goods to our partners. In these instances, we include the amounts in deferred revenue on our condensed consolidated balance sheet. Cost of Products Sold Our cost of products sold includes manufacturing costs, transportation and freight costs and indirect overhead costs associated with the manufacturing and distribution of our products. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval of TEGSEDI in July 2018 and WAYLIVRA in May 2019, we expensed a significant portion of the costs we incurred to produce the supply for each medicine we are using in the commercial launch as research and development expense. We previously expensed $ million and $ million of costs to produce our products related to the product sales revenue we recognized in the Noncontrolling Interest in Akcea Therapeutics, Inc. Prior to Akcea’s IPO in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second, third and fourth quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-L Rx Rx Rx The shares third parties own represent an interest in Akcea’s equity that is not controlled by us. However, as we continue to maintain overall control of Akcea through our voting interest, we reflect the assets, liabilities and results of operations of Akcea in our condensed consolidated financial statements. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. In addition, we record a noncontrolling interest adjustment to account for the stock options Akcea grants, which if exercised, will dilute our ownership in Akcea. This adjustment is a reclassification within stockholders’ equity from additional paid-in capital to noncontrolling interest in Akcea equal to the amount of stock-based compensation expense Akcea had recognized. Cash, Cash equivalents and Investments We consider all liquid investments with maturities of three months or less when we purchase them to be cash equivalents. Our short-term investments have initial maturities of greater than three months from date of purchase. We classify our short-term debt investments as “available-for-sale” and carry them at fair market value based upon prices on the last day of the fiscal period for identical or similar items. We record unrealized gains and losses on debt securities as a separate component of comprehensive income (loss) and include net realized gains and losses in gain (loss) on investments. We use the specific identification method to determine the cost of securities sold. We also have equity investments of less than 20 percent ownership in publicly and privately held biotechnology companies that we received as part of a technology license or partner agreement. At September 30, 2019, we held equity investments in two publicly held companies, ProQR Therapeutics N.V., or ProQR, and Antisense Therapeutics Limited, or ATL. We also held equity investments in four privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. Inventory Valuation We reflect our inventory on our condensed consolidated balance sheet at the lower of cost or market value under the first-in, first-out method, or FIFO. We capitalize the costs of raw materials that we purchase for use in producing our medicines because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for medicines that we manufacture for our partners under contractual terms and that we use primarily in our clinical development activities and drug products. We can use each of our raw materials in multiple products and, as a result, each raw material has future economic value independent of the development status of any single medicine. For example, if one of our medicines failed, we could use the raw materials for that medicine to manufacture our other medicines. We expense these costs as R&D expenses when we begin to manufacture API for a particular medicine if the medicine has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018 and in May 2019 for WAYLIVRA. At September 30, 2019, our physical inventory for TEGSEDI and WAYLIVRA included API that we produced prior to when we obtained regulatory approval. As such, this API has no cost basis as we had previously expensed the costs as R&D expenses. We review our inventory periodically and reduce the carrying value of items we consider to be slow moving or obsolete to their estimated net realizable value based on forecasted demand compared to quantities on hand. We consider several factors in estimating the net realizable value, including shelf life of our inventory, alternative uses for our medicines in development and historical write-offs. We did t record any material inventory write-offs for the . Total inventory was $ million and $ million as of , respectively. Leases Topic 842 Adoption In February 2016, the Financial Accounting Standards Board, or FASB, issued amended accounting guidance related to lease accounting. This guidance supersedes the lease requirements we previously followed in Accounting Standards Codification, or ASC, Topic 840, Leases Leases permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases we had in place as of January 1, 2019. Leases We determine if an arrangement contains a lease at inception. We currently only have operating leases. We recognize a right-of-use operating lease asset and associated short- and long-term operating lease liability on our condensed consolidated balance sheet for operating leases greater than one year. Our right-of-use assets represent our right to use an underlying asset for the lease term and our lease liabilities represent our obligation to make lease payments arising from the lease arrangement. We recognize our right-of-use operating lease assets and lease liabilities based on the present value of the future minimum lease payments we will pay over the lease term. As our current leases do not provide an interest rate implicit in the lease, we used our or Akcea’s incremental borrowing rate, based on the information available on the date we adopted Topic 842 or as of the lease inception date in determining the present value of future payments. Our right-of-use operating lease asset also includes any lease payments we made and excludes any tenant improvement allowances we received. We recognize rent expense for our minimum lease payments on a straight-line basis over the expected term of our lease. We recognize period expenses, such as common area maintenance expenses, in the period we incur the expense. Research, Development and Patent Expenses Our research and development expenses include wages, benefits, facilities, supplies, external services, clinical trial and manufacturing costs and other expenses that are directly related to our research and development operations. We expense research and development costs as we incur them. When we make payments for research and development services prior to the services being rendered, we record those amounts as prepaid assets on our condensed consolidated balance sheet and we expense them as the services are provided. We capitalize costs consisting principally of outside legal costs and filing fees related to obtaining patents. We amortize patent costs over the useful life of the patent, beginning with the date the United States Patent and Trademark Office, or foreign equivalent, issues the patent. We review our capitalized patent costs regularly to ensure that they include costs for patents and patent applications that have future value. We evaluate patents and patent applications that we are not actively pursuing and write off any associated costs. Income Taxes We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. We record a valuation allowance when necessary to reduce our net deferred tax assets to the amount expected to be realized. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017, or the Tax Act. The Tax Act created a new requirement on global intangible low-taxed income, or GILTI, earned by foreign subsidiaries for tax years beginning on or after January 1, 2018. The GILTI provisions require foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s assets to be included in our U.S. income tax return. Under U.S. GAAP, we are permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into our measurement of deferred taxes. We have made the election to account for GILTI as a component of current taxes incurred rather than as a component of deferred taxes. Long-lived Assets We evaluate long-lived assets, which include property, plant and equipment, right-of-use operating lease assets and patent costs acquired from third parties, for impairment on at least a quarterly basis and whenever events or changes in circumstances indicate that we may not be able to recover the carrying amount of such assets. Use of Estimates The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in our condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Basic and Diluted Net Income (Loss) Per Share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and nine months ended September 30, 2019 and 2018 considered our net income for Ionis on a stand-alone basis plus our share of Akcea’s net loss for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s loss per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net income per share for the three months ended September 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 70,221 $ (0.34 ) $ (23,772 ) Akcea’s net loss attributable to our ownership $ (23,772 ) Ionis’ stand-alone net income 49,930 Net income available to Ionis common stockholders $ 26,158 Weighted average shares outstanding 140,551 Basic net income per share $ 0.19 Our basic net income per share for the nine months ended Nine months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 69,681 $ (0.40 ) $ (28,174 ) Akcea’s net loss attributable to our ownership $ (28,174 ) Ionis’ stand-alone net income 140,938 Net income available to Ionis common stockholders $ 112,764 Weighted average shares outstanding 139,800 Basic net income per share $ 0.81 Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2018 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 65,538 $ (0.73 ) $ (47,843 ) Akcea’s net loss attributable to our ownership $ (47,843 ) Ionis’ stand-alone net income 43,226 Net loss available to Ionis |
Investments
Investments | 9 Months Ended |
Sep. 30, 2019 | |
Investments [Abstract] | |
Investments | 3. Investments As of September 30, 2019, we had invested our excess cash primarily in debt instruments of the U.S. Treasury, financial institutions, corporations, and U.S. government agencies with strong credit ratings and an investment grade rating at or above A-1, P-1 or F-1 by Moody’s, Standard & Poor’s, or S&P, or Fitch, respectively. We have established guidelines relative to diversification and maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity. The following table summarizes the contract maturity of the available-for-sale securities we held as of September 30, 2019: One year or less 69 % After one year but within two years 22 % After two years but within three years 9 % Total 100 % As illustrated above, at September 30, 2019, 91 percent of our available-for-sale securities had a maturity of less than two years. All of our available-for-sale securities are available to us for use in our current operations. As a result, we categorize all of these securities as current assets even though the stated maturity of some individual securities may be one year or more beyond the balance sheet date. At September 30, 2019, we had an ownership interest of less than 20 percent in four private companies and two public companies with which we conduct business. The privately-held companies are Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. The publicly-traded companies are ProQR and ATL. The following is a summary of our investments (in thousands): Gross Unrealized Estimated September 30, 2019 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 752,495 $ 1,484 $ (148 ) $ 753,831 Debt securities issued by U.S. government agencies 176,589 321 (45 ) 176,865 Debt securities issued by the U.S. Treasury (2) 331,371 264 (17 ) 331,618 Debt securities issued by states of the U.S. and political subdivisions of the states 33,986 4 (27 ) 33,963 Other municipal debt securities 2,948 — — 2,948 Total securities with a maturity of one year or less 1,297,389 2,073 (237 ) 1,299,225 Corporate debt securities 539,820 3,108 (161 ) 542,767 Debt securities issued by U.S. government agencies 106,536 101 (137 ) 106,500 Debt securities issued by the U.S. Treasury 34,692 — (38 ) 34,654 Debt securities issued by states of the U.S. and political subdivisions of the states 9,283 25 (6 ) 9,302 Total securities with a maturity of more than one year 690,331 3,234 (342 ) 693,223 Total available-for-sale securities $ 1,987,720 $ 5,307 $ (579 ) $ 1,992,448 Equity securities: Total equity securities included in other current assets (3) $ 1,212 $ — $ (606 ) $ 606 Total available-for-sale and equity securities $ 1,988,932 $ 5,307 $ (1,185 ) $ 1,993,054 Gross Unrealized Estimated December 31, 2018 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities $ 956,879 $ 13 $ (1,858 ) $ 955,034 Debt securities issued by U.S. government agencies 168,839 3 (104 ) 168,738 Debt securities issued by the U.S. Treasury 244,640 15 (77 ) 244,578 Debt securities issued by states of the U.S. and political subdivisions of the states (2) 63,572 — (323 ) 63,249 Total securities with a maturity of one year or less 1,433,930 31 (2,362 ) 1,431,599 Corporate debt securities 299,018 194 (1,286 ) 297,926 Debt securities issued by U.S. government agencies 107,789 194 (109 ) 107,874 Debt securities issued by the U.S. Treasury 15,600 — (24 ) 15,576 Debt securities issued by states of the U.S. and political subdivisions of the states 16,980 — (287 ) 16,693 Total securities with a maturity of more than one year 439,387 388 (1,706 ) 438,069 Total available-for-sale securities $ 1,873,317 $ 419 $ (4,068 ) $ 1,869,668 Equity securities: Total equity securities included in other current assets (3) 1,212 137 — 1,349 Total available-for-sale and equity securities $ 1,874,529 $ 556 $ (4,068 ) $ 1,871,017 (1) Our available-for-sale securities are held at amortized cost. (2) Includes investments classified as cash equivalents on our condensed consolidated balance sheet. (3) We recognize our equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer on our condensed consolidated balance sheet. The following is a summary of our investments we consider to be temporarily impaired at September 30, 2019. We believe that the decline in value of these securities is temporary and is primarily related to the change in market interest rates since purchase. We believe it is more likely than not that we will be able to hold our debt securities to maturity. Therefore, we anticipate full recovery of our debt securities’ amortized cost basis at maturity. Less than 12 Months of Temporary Impairment More than 12 Months of Temporary Impairment Total Temporary Impairment (In thousands) Number of Investments Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Corporate debt securities 104 $ 304,705 $ (268 ) $ 31,675 $ (41 ) $ 336,380 $ (309 ) Debt securities issued by U.S. government agencies 28 102,733 (156 ) 22,974 (26 ) 125,707 (182 ) Debt securities issued by the U.S. Treasury 9 77,918 (55 ) — — 77,918 (55 ) Debt securities issued by states of the U.S. and political subdivisions of the states 13 1,498 (1 ) 15,597 (32 ) 17,095 (33 ) Total temporarily impaired securities 154 $ 486,854 $ (480 ) $ 70,246 $ (99 ) $ 557,100 $ (579 ) |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements We use a three-tier fair value hierarchy to prioritize the inputs used in our fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets, which includes our money market funds and treasury securities classified as available-for-sale securities and our investment in equity securities in publicly-held biotechnology companies; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable, which includes our fixed income securities and commercial paper classified as available-for-sale securities; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring us to develop our own assumptions. We classify the majority of our securities as Level 2. We obtain the fair value of our Level 2 investments from our custodian bank or from a professional pricing service. We validate the fair value of our Level 2 investments by understanding the pricing model used by the custodian banks or professional pricing service provider and comparing that fair value to the fair value based on observable market prices. The following tables present the major security types we held at and that we regularly measure and carry at fair value. At and , subject to trading restrictions that extend to the fourth quarter of 2019; as a result, we The amount we owned in ProQR did not change from to . The tables below segregate each security type by the level within the fair value hierarchy of the valuation techniques we utilized to determine the respective securities’ fair value (in thousands): At September 30, 2019 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 202,904 $ 202,904 $ — $ — Corporate debt securities (2) 1,296,598 — 1,296,598 — Debt securities issued by U.S. government agencies (3) 283,365 — 283,365 — Debt securities issued by the U.S. Treasury (4) 366,272 366,272 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 43,265 — 43,265 — Other municipal debt securities (3) 2,948 — 2,948 — Investment in ProQR Therapeutics N.V. (5) 606 — — 606 Total $ 2,195,958 $ 569,176 $ 1,626,176 $ 606 At December 31, 2018 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 146,281 $ 146,281 $ — $ — Corporate debt securities (6) 1,252,960 — 1,252,960 — Debt securities issued by U.S. government agencies (3) 276,612 — 276,612 — Debt securities issued by the U.S. Treasury (7) 260,154 260,154 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 79,942 — 79,942 — Investment in ProQR Therapeutics N.V. (5) 1,349 — — 1,349 Total $ 2,017,298 $ 406,435 $ 1,609,514 $ 1,349 The following footnotes reference lines on our condensed consolidated balance sheet: (1) Included in cash and cash equivalents. (2) $16.6 million was included in cash and cash equivalents, with the difference included in short-term investments. (3) Included in short-term investments. (4) $3.0 million was included in cash and cash equivalents, with the difference included in short-term investments. (5) Included in other current assets. (6) $50.2 million was included in cash and cash equivalents, with the difference included in short-term investments. (7) $14.2 million was included in cash and cash equivalents, with the difference included in short-term investments. Convertible Notes Our 1 percent notes had a fair value of $783.7 million at September 30, 2019. We determine the fair value of our notes based on quoted market prices for these notes, which are Level 2 measurements because the notes do not trade regularly. |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Operating Leases | 5. Operating Leases We lease a facility adjacent to our manufacturing facility that has laboratory and office space that we use to support our manufacturing facility. We lease this space under a non-cancelable operating lease with an initial term ending in June 2021 and an option to extend the lease for up to two five-year periods. We also lease additional office space and we sublease a portion of this space to Akcea. We lease this space under a non-cancelable operating lease with an initial term ending in June 2023 and an option to extend the lease for one five-year period. The sublease with Akcea is eliminated in our condensed consolidated financial statements. Akcea entered into an operating lease agreement for office space located in Boston, Massachusetts for its new corporate headquarters in the second quarter of 2018. The lease commencement date was in August 2018 and Akcea took occupancy in September 2018. Akcea is leasing this space under a non-cancelable operating lease with an initial term ending after 123 months and an option to extend the lease for an additional five-year term. Under the lease agreement, Akcea received a three-month free rent period, which commenced on August 15, 2018, and a tenant improvement allowance up to $3.8 million. Akcea provided the lessor with a letter of credit to secure its obligations under the lease in the initial amount of $2.4 million, to be reduced to $1.8 million on the third anniversary of the rent commencement date and to $1.2 million on the fifth anniversary of the rent commencement date if Akcea meets certain conditions set forth in the lease at each such time. When we determined our lease term for our operating lease right-of-use assets and lease liabilities for these leases, we did not include the extension options for these leases. Amounts related to our operating leases were as follows (dollar amounts in millions): At September 30, 2019 Right-of-use operating lease assets (1) $ 13.0 Operating lease liabilities (2) $ 17.7 Weighted average remaining lease term 8.3 years Weighted average discount rate 7.5 % (1) Included in deposits and other assets on our condensed consolidated balance sheet. (2) Current portion of $2.1 million was included in current portion of long-term obligations on our condensed consolidated balance sheet, with the difference included in long-term obligations. During the nine months ended September 30, 2019, we paid $2.9 million of rent payments, which was included in operating activities in our condensed consolidated statement of cash flows. As of September 30, 2019, the payments for our operating lease liabilities are as follows (in thousands): Operating Leases Remainder of 2019 $ 801 Years ending December 31, 2020 3,282 2021 3,019 2022 2,781 2023 2,520 Thereafter 11,861 Total minimum lease payments 24,264 Less: Imputed interest (6,533 ) Total operating lease liabilities $ 17,731 Rent expense was $0.8 million and $1.0 million for the three months ended September 30, 2019 and 2018, respectively. Rent expense was $2.7 million and $1.8 million for the nine months ended September 30, 2019 and 2018, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | 6. Income Taxes We recorded an income tax benefit of $14.9 million and an income tax expense of $9.2 million for the three and nine months ended September 30, 2019, compared to income tax expense of $0.5 million and $0.8 million for the same periods in 2018, respectively. The tax benefit recorded for the three months ended September 30, 2019 varies from what we would have recorded using the U.S. federal statutory rate primarily due to a state tax benefit resulting from our combined state tax filings with Akcea, estimated R&D and orphan drug credits, excess tax benefits related to share-based compensation and a benefit related to a change in the estimated tax value of Akcea shares we received in 2018. The increase in our income tax expense for the nine months ended September 30, 2019, compared to the same period in 2018, was primarily due to our expectation that we will generate U.S. federal and state taxable income in 2019. We expect to utilize our deferred tax assets to partially offset our U.S. federal taxable income. |
Collaborative Arrangements and
Collaborative Arrangements and Licensing Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Collaborative Arrangements and Licensing Agreements | 7. Collaborative Arrangements and Licensing Agreements Below, we have included our collaborations with substantive changes during the first nine months of 2019 from those included in Note 6 of our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. Strategic Partnership Biogen We have several strategic collaborations with Biogen focused on using antisense technology to advance the treatment of neurological disorders. These collaborations combine our expertise in creating antisense medicines with Biogen’s expertise in developing therapies for neurological disorders. We developed and licensed to Biogen SPINRAZA, our approved medicine to treat people with spinal muscular atrophy, or SMA. In new antisense medicines for the treatment of SMA We and Biogen are currently developing medicines under collaborations, including medicines to treat people with ALS, Alzheimer’s disease and Parkinson’s disease. In addition to these medicines, our collaborations with Biogen include a substantial research pipeline that addresses a broad range of neurological diseases. From inception through September 2019, we have received $ billion from our Biogen collaborations, including $ billion we received from Biogen in the second quarter of 2018 for our 2018 strategic neurology collaboration. During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 SPINRAZA royalties (commercial revenue) $ 81.7 $ 70.0 $ 211.9 $ 167.7 R&D revenue 25.5 34.8 81.9 66.9 Total revenue from our relationship with Biogen $ 107.2 $ 104.8 $ 293.8 $ 234.6 Percentage of total revenue 64 % 72 % 47 % 58 % Neurology Collaborations 2018 Strategic Neurology In the second quarter of 2019, we achieved two $7.5 million milestone payments from Biogen when we advanced two new targets for unidentified neurological diseases We will achieve the next payment of $7.5 million if Biogen designates another target under this collaboration. 2013 Strategic Neurology In the third quarter of 2019, we achieved an $8 million milestone payment when Biogen initiated a Phase 1/2 study of ION859 (IONIS-LRRK2 Rx for the treatment of people with Parkinson’s disease From inception through September 2019, we have included $145 million in total payments in the transaction price for our R&D services performance obligation under this collaboration that we are recognizing over our estimated period of performance. We are recognizing revenue as we perform services based on our effort to satisfy our performance obligation relative to the total effort expected to satisfy our performance obligation. In the third quarter of 2019, we updated our estimate of the total effort we expect to expend to satisfy our performance obligation. As of September 30, 2019, we have completed a significant portion of the research and development services. We expect to complete the remainder of our services in 2020. 2012 Neurology In the second quarter of 2019, we achieved a $7.5 million milestone payment from Biogen when we advanced IONIS-MAPT Rx for Alzheimer’s disease Rx Rx Rx Rx We also have a separate performance obligation to perform R&D services under this collaboration. We have allocated $40 million in total payments to the transaction price for our R&D services performance obligation. In the third quarter of 2019, we completed our R&D services performance obligation when we designated a development candidate and Biogen accepted the development candidate. Biogen’s decision to accept the development candidate was not within our control. We were recognizing revenue as we performed services based on our effort to satisfy our performance obligation relative to the total effort expected to satisfy our performance obligation. Because Biogen accepted the development candidate, we recognized $6.3 million of accelerated revenue in the third quarter of 2019. We will achieve the next payment of up to $10 million if we advance a program under this collaboration. During the nine months of 2019, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our Biogen collaborations, except as noted above. Our condensed consolidated balance sheet at September 30, 2019 and December 31, 2018 Research, Development and Commercialization Partners Bayer In May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize our programs targeting FXI for the treatment of clotting disorders. In October 2019, Bayer decided it would advance IONIS-FXI-L Rx GSK In March 2010, we entered into an alliance with GSK using our antisense drug discovery platform to discover and develop new drugs against targets for rare and serious diseases, including infectious diseases and some conditions causing blindness. Our collaboration with GSK includes two drugs targeting hepatitis B virus, or HBV: IONIS-HBV Rx Rx We identified a new performance obligation when we granted GSK the license of the HBV program and assignment of related intellectual property rights in the third quarter of 2019 because the license is distinct from our other performance obligations. We recognized the $25 million license fee for the HBV program as revenue at that time because GSK had full use of the license without any continuing involvement from us. Additionally, we did not have any further performance obligations related to the license after we delivered it to GSK. During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with GSK (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 25.1 $ 0.1 $ 25.3 $ 1.5 Percentage of total revenue 15 % 0 % 4 % 0 % We did not have any deferred revenue from our relationship with GSK at September 30, 2019 or December 31, 2018. Roche We have collaborations with Roche, to develop treatments for Huntington's disease, or HD, and to develop IONIS-FB-L Rx for the treatment of complement-mediated diseases. In December 2017, upon completion of the Phase 1/2 study of IONIS-HTT Rx , Roche exercised its option to license IONIS-HTT Rx and is now responsible for the global development, regulatory and commercialization activities for IONIS-HTT Rx . In October 2018, we entered into a collaboration agreement with Roche to develop IONIS-FB-L Rx for the treatment of complement-mediated diseases. The first indication we plan to pursue is the treatment of patients with geographic atrophy, or GA, the advanced stage of dry age-related macular degeneration, or AMD. We are responsible for conducting a Phase 2 study in patients with dry AMD. In addition, we plan to evaluate the medicine for a severe and rare renal indication. has the option to license IONIS-FB-L Rx at the completion of these studies. Upon licensing, will be responsible for all further global development, regulatory and commercialization activities and costs. From inception through June 2019, we have received over $ million from our Roche collaborations, including $ million in milestone payments we earned in the first quarter of 2019 when Roche dosed the first patient in a Phase 3 study for IONIS-HTT Rx . We will achieve the next payment of $ million if Roche advances IONIS-HTT Rx . During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 4.7 $ 1.8 $ 52.3 $ 5.4 Percentage of total revenue 3 % 1 % 8 % 1 % Our revenue in the first nine months of 2019 included $35 million of milestone payments we earned when Roche dosed the first patient in the Phase 3 study of IONIS-HTT Rx Rx During the first nine months of 2019, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our Roche collaborations. Our condensed consolidated balance sheet at September 30, 2019 and December 31, 2018 Akcea Collaborations The following collaboration agreements relate to Akcea, our majority owned affiliate. Our consolidated results include all the revenue earned and cash received under this collaboration agreement. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. Novartis In January 2017, we and Akcea initiated a collaboration with Novartis to develop and commercialize AKCEA-APO(a)-L Rx and AKCEA-APOCIII-L Rx . Under the collaboration agreement, Novartis has an exclusive option to further develop and commercialize AKCEA-APO(a)-L Rx and AKCEA-APOCIII-L Rx . Akcea is responsible for completing a Phase 2 program, conducting an end-of-Phase 2 meeting with the FDA and providing initial quantities of API for each medicine. If Novartis exercises an option for either of these medicines, Novartis will be responsible for all further global development, regulatory and co-commercialization activities and costs for such medicine. Rx Rx From inception through September 2019, we have received over $ million from our Novartis collaboration, including $ million we earned from Novartis in the first quarter of 2019 for the license of AKCEA-APO(a)-L Rx We identified a new performance obligation when we granted Novartis the license of AKCEA-APO(a)-L Rx Rx Novartis has the option to purchase additional API of AKCEA-APO(a)-L Rx Rx Akcea is responsible for the development activities under this collaboration. As such, Akcea is recognizing the associated revenue in its statement of operations, and we reflect all of Akcea’s revenue in our consolidated results. Akcea pays us sublicense fees for payments that it receives under the collaboration and we recognize those fees as revenue in our Ionis Core operating segment results and Akcea recognizes the fees as R&D expense. In our consolidated results, we eliminate this sublicense revenue and expense. Any cash Akcea receives is included in our condensed consolidated balance sheet. During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 8.5 $ 7.2 $ 176.3 $ 42.7 Percentage of total revenue 5 % 5 % 28 % 10 % During the first nine months of 2019, we did not have any changes to our performance obligations, except as noted above, or the timing in which we expect to recognize revenue under our Novartis collaboration. Our condensed consolidated balance sheet at September 30, 2019 and December 31, 2018 included deferred revenue of $10.8 million and $28.8 million, respectively, related to our relationship with Novartis. Pfizer In October 2019, Akcea initiated a collaboration with Pfizer for the license of AKCEA -ANGPTL3-L Rx -ANGPTL3-L Rx Under the terms of the agreement, Akcea will receive a $ million upfront license fee, upon closing the transaction, including receiving Hart-Scott Rodino clearance. Akcea is also eligible to receive development, regulatory and sales milestone payments of up to $ billion and tiered royalties in the mid-teens to low- range on annual worldwide net sales. Akcea has retained the rights to co-commercialize AKCEA -ANGPTL3-L Rx in the U.S. and certain additional markets. The license fee, milestone payments and royalties will be split equally between us and Akcea. Upon receipt of the upfront payment from Pfizer In October 2019, Akcea initiated a collaboration with Pfizer for the license of AKCEA -ANGPTL3-L Rx to treat people with cardiovascular and metabolic diseases. Under the terms of the agreement, Akcea will receive a $ million upfront license fee, upon closing the transaction, including receiving Hart-Scott Rodino clearance. in the mid-teens to low-20 percent range Upon receipt of the upfront payment from Pfizer |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2019 | |
Segment Information [Abstract] | |
Segment Information | 8. Segment Information We have reportable segments, Ionis Core and Akcea Therapeutics. Segment income (loss) from operations includes revenue less operating expenses attributable to each segment. In our Ionis Core segment we are exploiting our antisense technology to generate a broad pipeline of first-in-class and/or best-in-class medicines for us and our partners. Our Ionis Core segment generates revenue from a multifaceted partnering strategy. Akcea is . Akcea generates revenue from TEGSEDI and WAYLIVRA product sales and from its collaborations. The following tables show our segment revenue and income (loss) from operations for the three and nine months ended September 30, 2019 and 2018 (in thousands), respectively. Three Months Ended September 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 81,672 $ — $ — $ 81,672 Product sales, net — 11,945 — 11,945 Licensing and other royalty revenue 1,946 136 — 2,082 Total commercial revenue 83,618 12,081 — 95,699 R&D revenue under collaborative agreements 69,165 8,543 (5,515 ) 72,193 Total segment revenue $ 152,783 $ 20,624 $ (5,515 ) $ 167,892 Total operating expenses $ 119,147 $ 53,215 $ (6,993 ) $ 165,369 Income (loss) from operations $ 33,636 $ (32,591 ) $ 1,478 $ 2,523 Three Months Ended September 30, 2018 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 70,010 $ — $ — $ 70,010 Licensing and other royalty revenue 7,946 12,000 (7,200 ) 12,746 Total commercial revenue 77,956 12,000 (7,200 ) 82,756 R&D revenue under collaborative agreements 100,105 7,241 (44,707 ) 62,639 Total segment revenue $ 178,061 $ 19,241 $ (51,907 ) $ 145,395 Total operating expenses $ 87,664 $ 84,249 $ (7,946 ) $ 163,967 Income (loss) from operations $ 90,397 $ (65,008 ) $ (43,961 ) $ (18,572 ) Nine Months Ended September 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 211,884 $ — $ — $ 211,884 Product sales, net — 28,563 — 28,563 Licensing and other royalty revenue 8,466 6,172 (3,000 ) 11,638 Total commercial revenue 220,350 34,735 (3,000 ) 252,085 R&D revenue under collaborative agreements 294,512 176,328 (94,007 ) 376,833 Total segment revenue $ 514,862 $ 211,063 $ (97,007 ) $ 628,918 Total operating expenses $ 355,437 $ 256,152 $ (87,900 ) $ 523,689 Income (loss) from operations $ 159,425 $ (45,089 ) $ (9,107 ) $ 105,229 Nine Months Ended September 30, 2018 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 167,743 $ — $ — $ 167,743 Licensing and other royalty revenue 9,432 12,000 (7,200 ) 14,232 Total commercial revenue 177,175 12,000 (7,200 ) 181,975 R&D revenue under collaborative agreements 232,850 42,670 (49,936 ) 225,584 Total segment revenue $ 410,025 $ 54,670 $ (57,136 ) $ 407,559 Total operating expenses $ 279,084 $ 213,428 $ (12,796 ) $ 479,716 Income (loss) from operations $ 130,941 $ (158,758 ) $ (44,340 ) $ (72,157 ) The following table shows our total assets by segment at September 30, 2019 and December 31, 2018 (in thousands), respectively. Total Assets Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total September 30, 2019 $ 3,233,175 $ 383,167 $ (721,353 ) $ 2,894,989 December 31, 2018 $ 2,975,491 $ 365,261 $ (672,968 ) $ 2,667,784 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | We prepared the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2019 and 2018 on the same basis as the audited financial statements for the year ended December 31, 2018. We included all normal recurring adjustments in the financial statements, which we considered necessary for a fair presentation of our financial position at such dates and our operating results and cash flows for those periods. Results for the interim periods are not necessarily indicative of the results for the entire year. For more complete financial information, these financial statements, and notes thereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2018 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC. |
Consolidation | In the condensed consolidated financial statements, we included the accounts of Ionis Pharmaceuticals, Inc. and the consolidated results of our majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries. We formed Akcea in December 2014. initial public offering, or IPO, Rx. Rx Refer to the section titled “Noncontrolling Interest in Akcea” in Note 2, Significant Accounting Policies, for further information related to our accounting for our investment in Akcea. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Significant Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition Our Revenue Sources We generally recognize revenue when we have satisfied all contractual obligations and are reasonably assured of collecting the resulting receivable. We are often entitled to bill our customers and receive payment from our customers in advance of recognizing the revenue. In the instances in which we have received payment from our customers in advance of recognizing revenue, we include the amounts in deferred revenue on our consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Commercial Revenue: Product sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 and we added product sales from WAYLIVRA to our commercial revenue in the third quarter of 2019. Research and development revenue under collaborative agreements We often enter into collaboration agreements to license and sell our technology on an exclusive or non-exclusive basis. Our collaboration agreements typically contain multiple elements, or performance obligations, including technology licenses or options to obtain technology licenses, research and development, or R&D, services, and manufacturing services. We provide details about our collaboration agreements in Note 7, Collaborative Arrangements and Licensing Agreements, in our Annual Report on Form 10-K for the year ended December 31, 2018 . Under each collaboration note we discuss our specific revenue recognition conclusions, including our significant performance obligations under each collaboration. Steps to Recognize Revenue We use a five-step process to determine the amount of revenue we should recognize and when we should recognize it. The five step process is as follows: 1. Identify the contract Accounting rules require us to first determine if we have a contract with our partner, including confirming that we have met each of the following criteria: ● We and our partner approved the contract and we are both committed to perform our obligations; ● We have identified our rights, our partner’s rights and the payment terms; ● We have concluded that the contract has commercial substance, meaning that the risk, timing, or amount of our future cash flows is expected to change as a result of the contract; and ● We believe collectability is probable. 2. Identify the performance obligations We next identify the distinct goods and services we are required to provide under the contract. Accounting rules refer to these as our performance obligations. We typically have only one performance obligation at the inception of a contract, which is to perform R&D services. Often times we enter into a collaboration agreement in which we provide our partner with an option to license a medicine in the future. We may also provide our partner with an option to request that we provide additional goods or services in the future, such as active pharmaceutical ingredient, or API. We evaluate whether these options are material rights at the inception of the agreement. If we determine an option is a material right, we will consider the option a separate performance obligation. Historically, we have concluded that the options we grant to license a medicine in the future or to provide additional goods and services as requested by our partner are not material rights. These items are contingent upon future events that may not occur. When a partner exercises its option to license a medicine or requests additional goods or services, then we identify a new performance obligation for that item. In some cases, we deliver a license at the start of an agreement. If we determine that our partner has full use of the license and we do not have any additional material performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation. 3. Determine the transaction price We then determine the transaction price by reviewing the amount of consideration we are eligible to earn under the collaboration agreement, including any variable consideration. Under our collaboration agreements, consideration typically includes fixed consideration in the form of an upfront payment and variable consideration in the form of potential milestone payments, license fees and royalties. At the start of an agreement, our transaction price usually consists of only the upfront payment. We do not typically include any payments we may receive in the future in our initial transaction price because the payments are not probable and are contingent on certain events. We reassess the total transaction price at each reporting period to determine if we should include additional payments in the transaction price. Milestone payments are our most common type of variable consideration. We recognize milestone payments using the most likely amount method because we will either receive the milestone payment or we will not, which makes the potential milestone payment a binary event. The most likely amount method requires us to determine the likelihood of earning the milestone payment. We include a milestone payment in the transaction price once it is probable we will achieve the milestone event. Most often, we do not consider our milestone payments probable until we or our partner achieve the milestone event because the majority of our milestone payments are contingent upon events that are not within our control and are usually based on scientific progress. For example, in the first quarter of 2019, we earned $35 million in milestone payments from Roche when Roche dosed the first patient in the Phase 3 study of IONIS-HTT Rx 4. Allocate the transaction price Next, we allocate the transaction price to each of our performance obligations. When we have to allocate the transaction price to more than one performance obligation, we make estimates of the relative stand-alone selling price of each performance obligation because we do not typically sell our goods or services on a stand-alone basis. We then allocate the transaction price to each performance obligation based on the relative stand-alone selling price. We may engage a third party, independent valuation specialist to assist us with determining a stand-alone selling price for collaborations in which we deliver a license at the start of an agreement. We estimate the stand-alone selling price of these licenses using valuation methodologies, such as the relief from royalty method. Under this method, we estimate the amount of income, net of taxes, for the license. We then discount the projected income to present value. The significant inputs we use to determine the projected income of a license could include: ● Estimated future product sales; ● Estimated royalties on future product sales; ● Contractual milestone payments; ● Expenses we expect to incur; ● Income taxes; and ● A discount rate. We typically estimate the selling price of R&D services by using our internal estimates of the cost to perform the specific services. The significant inputs we use to determine the selling price of our R&D services include: ● The number of internal hours we estimate we will spend performing these services; ● The estimated cost of work we will perform; ● The estimated cost of work that we will contract with third parties to perform; and ● The estimated cost of API we will use. For purposes of determining the stand-alone selling price of the R&D services we perform and the API we will deliver, accounting guidance requires us to include a markup for a reasonable profit margin. We do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices. 5. Recognize revenue We recognize revenue in one of two ways, over time or at a point in time. We recognize revenue over time when we are executing on our performance obligation over time and our partner receives benefit over time. For example, we recognize revenue over time when we provide R&D services. We recognize revenue at a point in time when our partner receives full use of an item at a specific point in time. For example, we recognize revenue at a point in time when we deliver a license or API to a partner. For R&D services that we recognize over time, we measure our progress using an input method. The input methods we use are based on the effort we expend or costs we incur toward the satisfaction of our performance obligation. We estimate the amount of effort we expend, including the time we estimate it will take us to complete the activities, or costs we incur in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This results in a percentage that we multiply by the transaction price to determine the amount of revenue we recognize each period. This approach requires us to make numerous estimates and use significant judgement. If our estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that we recognize in the current and future periods. For example, 2013 Strategic Neurology collaboration with Biogen significant portion of the research and development services. We expect to complete the remainder of our services in 2020. As a result of our change in estimate, in the third quarter of 2019, we recorded a cumulative catch up adjustment of $ million to decrease revenue. We expect to complete the remainder of our services in 2020. Refer to Note 7, Collaborative Arrangements and Licensing Agreements , for further discussion of the cumulative catch up adjustment we made. The following are examples of when we typically recognize revenue based on the types of payments we receive. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We recognize royalty revenue in the period in which the counterparty sells the related product, which in certain cases may require us to estimate our royalty revenue. Commercial Revenue: Product sales, net We recognize product sales in the period Reserves for Product sales We record product sales at our net sales price, or transaction price. We include in our transaction price estimated reserves for discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that we offer within contracts between us and our customers, wholesalers, health care providers and other indirect customers. We estimate our reserves using the amounts we have earned or what we can claim on the associated sales. We classify our reserves as a reduction of accounts receivable when we are not required to make a payment or as a current liability when we are required to make a payment. In certain cases, our estimates include a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, our reserves reflect our best estimates under the terms of our respective contracts. When calculating our reserves and related product sales, we only recognize amounts to the extent that we consider it probable that we would not have to reverse in a future period a significant amount of the cumulative sales we previously recognized. The actual amounts we receive may ultimately differ from our reserve estimates. If actual amounts in the future vary from our estimates, we will adjust these estimates, which would affect our net product sales in the respective period. The following are the components of variable consideration related to product sales: Chargebacks: Government rebates : We are subject t Trade discounts: Distribution services Product returns: Other incentives: Research and development revenue under collaboration agreements: Upfront payments When we enter into a collaboration agreement with an upfront payment, we typically record the entire upfront payment as deferred revenue if our only performance obligation is for R&D services we will provide in the future. We amortize the upfront payment into revenue as we perform the R&D services. For example, under our collaboration agreement with Roche to develop IONIS-FB-L Rx for the treatment of complement-mediated diseases Milestone payments We are required to include additional consideration in the transaction price when it is probable. We typically include milestone payments for R&D services in the transaction price when they are achieved. We include these milestone payments when they are achieved because there is considerable uncertainty in the research and development processes that trigger these payments under our collaboration agreements. Similarly, we include approval milestone payments in the transaction price once the medicine is approved by the applicable regulatory agency. We will recognize sales-based milestone payments in the period in which we achieve the milestone under the sales-based royalty exception allowed under accounting rules. We recognize milestone payments that relate to an ongoing performance obligation over our period of performance. For example, in the second quarter of 2019, we achieved a $7.5 million milestone payment from Biogen when we advanced a new target for an unidentified neurological disease under our 2018 strategic neurology collaboration. We added this payment to the transaction price and allocated it to our R&D services performance obligation. We are recognizing revenue related to this milestone payment over our estimated period of performance. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event and we do not have a performance obligation. For example, in the third quarter of 2019, we recognized an $8 million milestone payment when Biogen initiated a Phase 1/2 study of IONIS-LRRK2 Rx (BIIB094) for the treatment of people with Parkinson’s disease We concluded that the milestone payment was not related to our R&D services performance obligation. Therefore, we recognized the milestone payment in full in the third quarter of 2019. License fees We generally recognize as revenue the total amount we determine to be the stand-alone selling price of a license when we deliver the license to our partner. This is because our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery. Sublicense fees We recognize sublicense fee revenue in the period in which a party, who has already licensed our technology, further licenses the technology to another party because we do not have any performance obligations related to the sublicense. Amendments to agreements From time to time we amend our collaboration agreements. When this occurs, we are required to assess the following items to determine the accounting for the amendment: 1) If the additional goods and/or services are distinct from the other performance obligations in the original agreement; and 2) If the goods and/or services are at a stand-alone selling price. If we conclude the goods and/or services in the amendment are distinct from the performance obligations in the original agreement and at a stand-alone selling price, we account for the amendment as a separate agreement. If we conclude the goods and/or services are not distinct and at their stand-alone selling price, we then assess whether the remaining goods or services are distinct from those already provided. If the goods and/or services are distinct from what we have already provided, then we allocate the remaining transaction price from the original agreement and the additional transaction price from the amendment to the remaining goods and/or services. If the goods and/or services are not distinct from what we have already provided, we update the transaction price for our single performance obligation and recognize any change in our estimated revenue as a cumulative adjustment. For example, in May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize IONIS-FXI Rx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $ million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXI Rx in people with end-stage renal disease on hemodialysis and for providing an initial supply of API. In February 2017, we amended our agreement with Bayer to advance IONIS-FXI Rx and to initiate development of IONIS-FXI-L Rx , which Bayer licensed. As part of the 2017 amendment, Bayer paid us $ million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXI Rx and IONIS-FXI-L Rx . Under the 2017 amendment, we concluded we had a new agreement with performance obligations. These performance obligations were to deliver the license of IONIS-FXI-L Rx , to provide R&D services and to deliver API. We allocated the $ million transaction price to these performance obligations. Note 7, Collaborative Arrangements and Licensing Agreements of our accounting treatment for our Bayer collaboration. Multiple agreements From time to time, we may enter into separate agreements at or near the same time with the same partner. We evaluate such agreements to determine whether we should account for them individually as distinct arrangements or whether the separate agreements should be combined and accounted for together. We evaluate the following to determine the accounting for the agreements: ● Whether the agreements were negotiated together with a single objective; ● Whether the amount of consideration in one contract depends on the price or performance of the other agreement; or ● Whether the goods and/or services promised under the agreements are a single performance obligation. Our evaluation involves significant judgment to determine whether a group of agreements might be so closely related that accounting guidance requires us to account for them as a combined arrangement. For example, in the second quarter of 2018, we entered into two separate agreements with Biogen at the same time: a new strategic neurology collaboration agreement and a stock purchase agreement, or SPA. We evaluated the Biogen agreements to determine whether we should treat the agreements separately or combine them. We considered that the agreements were negotiated concurrently and in contemplation of one another. Based on these facts and circumstances, we concluded that we should evaluate the provisions of the agreements on a combined basis. |
Contracts Receivable | Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners or customers and that are due to us unconditionally for goods we have delivered or services we have performed. When we bill our partners or customers with payment terms based on the passage of time, we consider the contract receivable to be unconditional. We typically receive payment within one quarter of billing our partner or customer |
Unbilled SPINRAZA Royalties | Unbilled SPINRAZA Royalties Our unbilled SPINRAZA royalties represent our right to receive consideration from Biogen in advance of when we are eligible to bill Biogen for SPINRAZA royalties. We include these unbilled amounts in other current assets on our condensed consolidated balance sheet. |
Deferred Revenue | Deferred Revenue We are often entitled to bill our customers and receive payment from our customers in advance of our obligation to provide services or transfer goods to our partners. In these instances, we include the amounts in deferred revenue on our condensed consolidated balance sheet. |
Cost of Products Sold | Cost of Products Sold Our cost of products sold includes manufacturing costs, transportation and freight costs and indirect overhead costs associated with the manufacturing and distribution of our products. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval of TEGSEDI in July 2018 and WAYLIVRA in May 2019, we expensed a significant portion of the costs we incurred to produce the supply for each medicine we are using in the commercial launch as research and development expense. We previously expensed $ million and $ million of costs to produce our products related to the product sales revenue we recognized in the |
Noncontrolling Interest in Akcea Therapeutics, Inc. | Noncontrolling Interest in Akcea Therapeutics, Inc. Prior to Akcea’s IPO in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second, third and fourth quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-L Rx Rx Rx The shares third parties own represent an interest in Akcea’s equity that is not controlled by us. However, as we continue to maintain overall control of Akcea through our voting interest, we reflect the assets, liabilities and results of operations of Akcea in our condensed consolidated financial statements. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. In addition, we record a noncontrolling interest adjustment to account for the stock options Akcea grants, which if exercised, will dilute our ownership in Akcea. This adjustment is a reclassification within stockholders’ equity from additional paid-in capital to noncontrolling interest in Akcea equal to the amount of stock-based compensation expense Akcea had recognized. |
Cash, Cash Equivalents and Investments | Cash, Cash equivalents and Investments We consider all liquid investments with maturities of three months or less when we purchase them to be cash equivalents. Our short-term investments have initial maturities of greater than three months from date of purchase. We classify our short-term debt investments as “available-for-sale” and carry them at fair market value based upon prices on the last day of the fiscal period for identical or similar items. We record unrealized gains and losses on debt securities as a separate component of comprehensive income (loss) and include net realized gains and losses in gain (loss) on investments. We use the specific identification method to determine the cost of securities sold. We also have equity investments of less than 20 percent ownership in publicly and privately held biotechnology companies that we received as part of a technology license or partner agreement. At September 30, 2019, we held equity investments in two publicly held companies, ProQR Therapeutics N.V., or ProQR, and Antisense Therapeutics Limited, or ATL. We also held equity investments in four privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. |
Inventory Valuation | Inventory Valuation We reflect our inventory on our condensed consolidated balance sheet at the lower of cost or market value under the first-in, first-out method, or FIFO. We capitalize the costs of raw materials that we purchase for use in producing our medicines because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for medicines that we manufacture for our partners under contractual terms and that we use primarily in our clinical development activities and drug products. We can use each of our raw materials in multiple products and, as a result, each raw material has future economic value independent of the development status of any single medicine. For example, if one of our medicines failed, we could use the raw materials for that medicine to manufacture our other medicines. We expense these costs as R&D expenses when we begin to manufacture API for a particular medicine if the medicine has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018 and in May 2019 for WAYLIVRA. At September 30, 2019, our physical inventory for TEGSEDI and WAYLIVRA included API that we produced prior to when we obtained regulatory approval. As such, this API has no cost basis as we had previously expensed the costs as R&D expenses. We review our inventory periodically and reduce the carrying value of items we consider to be slow moving or obsolete to their estimated net realizable value based on forecasted demand compared to quantities on hand. We consider several factors in estimating the net realizable value, including shelf life of our inventory, alternative uses for our medicines in development and historical write-offs. We did t record any material inventory write-offs for the . Total inventory was $ million and $ million as of , respectively. |
Leases | Leases Topic 842 Adoption In February 2016, the Financial Accounting Standards Board, or FASB, issued amended accounting guidance related to lease accounting. This guidance supersedes the lease requirements we previously followed in Accounting Standards Codification, or ASC, Topic 840, Leases Leases permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases we had in place as of January 1, 2019. Leases We determine if an arrangement contains a lease at inception. We currently only have operating leases. We recognize a right-of-use operating lease asset and associated short- and long-term operating lease liability on our condensed consolidated balance sheet for operating leases greater than one year. Our right-of-use assets represent our right to use an underlying asset for the lease term and our lease liabilities represent our obligation to make lease payments arising from the lease arrangement. We recognize our right-of-use operating lease assets and lease liabilities based on the present value of the future minimum lease payments we will pay over the lease term. As our current leases do not provide an interest rate implicit in the lease, we used our or Akcea’s incremental borrowing rate, based on the information available on the date we adopted Topic 842 or as of the lease inception date in determining the present value of future payments. Our right-of-use operating lease asset also includes any lease payments we made and excludes any tenant improvement allowances we received. We recognize rent expense for our minimum lease payments on a straight-line basis over the expected term of our lease. We recognize period expenses, such as common area maintenance expenses, in the period we incur the expense. |
Research and Development Expenses | Our research and development expenses include wages, benefits, facilities, supplies, external services, clinical trial and manufacturing costs and other expenses that are directly related to our research and development operations. We expense research and development costs as we incur them. When we make payments for research and development services prior to the services being rendered, we record those amounts as prepaid assets on our condensed consolidated balance sheet and we expense them as the services are provided. |
Patent Expenses | We capitalize costs consisting principally of outside legal costs and filing fees related to obtaining patents. We amortize patent costs over the useful life of the patent, beginning with the date the United States Patent and Trademark Office, or foreign equivalent, issues the patent. We review our capitalized patent costs regularly to ensure that they include costs for patents and patent applications that have future value. We evaluate patents and patent applications that we are not actively pursuing and write off any associated costs. |
Income Taxes | Income Taxes We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. We record a valuation allowance when necessary to reduce our net deferred tax assets to the amount expected to be realized. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017, or the Tax Act. The Tax Act created a new requirement on global intangible low-taxed income, or GILTI, earned by foreign subsidiaries for tax years beginning on or after January 1, 2018. The GILTI provisions require foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s assets to be included in our U.S. income tax return. Under U.S. GAAP, we are permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into our measurement of deferred taxes. We have made the election to account for GILTI as a component of current taxes incurred rather than as a component of deferred taxes. |
Long-Lived Assets | Long-lived Assets We evaluate long-lived assets, which include property, plant and equipment, right-of-use operating lease assets and patent costs acquired from third parties, for impairment on at least a quarterly basis and whenever events or changes in circumstances indicate that we may not be able to recover the carrying amount of such assets. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in our condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
Basic and Diluted Net Income (Loss) per Share | Basic and Diluted Net Income (Loss) Per Share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and nine months ended September 30, 2019 and 2018 considered our net income for Ionis on a stand-alone basis plus our share of Akcea’s net loss for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s loss per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net income per share for the three months ended September 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 70,221 $ (0.34 ) $ (23,772 ) Akcea’s net loss attributable to our ownership $ (23,772 ) Ionis’ stand-alone net income 49,930 Net income available to Ionis common stockholders $ 26,158 Weighted average shares outstanding 140,551 Basic net income per share $ 0.19 Our basic net income per share for the nine months ended Nine months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 69,681 $ (0.40 ) $ (28,174 ) Akcea’s net loss attributable to our ownership $ (28,174 ) Ionis’ stand-alone net income 140,938 Net income available to Ionis common stockholders $ 112,764 Weighted average shares outstanding 139,800 Basic net income per share $ 0.81 Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2018 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 65,538 $ (0.73 ) $ (47,843 ) Akcea’s net loss attributable to our ownership $ (47,843 ) Ionis’ stand-alone net income 43,226 Net loss available to Ionis common stockholders $ (4,617 ) Weighted average shares outstanding 137,346 Basic net loss per share $ (0.03 ) Our basic net loss per share for the nine months ended Nine months ended September 30, 2018 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 57,347 $ (1.93 ) $ (110,680 ) Akcea’s net loss attributable to our ownership $ (110,680 ) Ionis’ stand-alone net income 67,517 Net loss available to Ionis common stockholders $ (43,163 ) Weighted average shares outstanding 130,507 Basic net loss per share $ (0.33 ) Dilutive net income (loss per share) For the three and nine months ended September 30, 2019, we had net income available to Ionis common stockholders. As a result, we computed diluted net income per share using the weighted-average number of common shares and dilutive common equivalent shares outstanding during the period. We calculated our diluted net income per share for the three months ended September 30, 2019 as follows (in thousands except per share amounts): Three months ended September 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 26,158 140,551 $ 0.19 Effect of dilutive securities: Shares issuable upon exercise of stock options — 1,993 Shares issuable upon restricted stock award issuance — 844 Shares issuable related to our Employee Stock Purchase Plan — 20 Income available to Ionis common stockholders $ 26,158 143,408 $ 0.18 We calculated our diluted net income per share for the nine months ended September 30, 2019 as follows (in thousands except per share amounts): Nine months ended September 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 112,764 139,800 $ 0.81 Effect of dilutive securities: Shares issuable upon exercise of stock options — 2,208 Shares issuable upon restricted stock award issuance — 793 Shares issuable related to our Employee Stock Purchase Plan — 20 Income available to Ionis common stockholders $ 112,764 142,821 $ 0.79 For the three and nine months ended September 30, 2019, the calculation excluded the 1 percent notes because the effect on diluted earnings per share was anti-dilutive. For the three and nine months ended September 30, 2018, we incurred a net loss; therefore, we did not include dilutive common equivalent shares in the computation of diluted net loss per share because the effect would have been anti-dilutive. Common stock from the following would have had an anti-dilutive effect on net loss per share: ● 1 percent convertible senior notes; ● Dilutive stock options; ● Unvested restricted stock units; and ● Employee Stock Purchase Plan, or ESPP. |
Convertible Debt | Convertible Debt We account for convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) by separating the liability and equity components of the instruments in a manner that reflects our nonconvertible debt borrowing rate. We determine the carrying amount of the liability component by measuring the fair value of similar debt instruments that do not have the conversion feature. If no similar debt instrument exists, we estimate fair value by using assumptions that market participants would use in pricing a debt instrument, including market interest rates, credit standing, yield curves and volatilities. To determine the fair value of the debt component we are required to use accounting estimates and assumptions. These estimates and assumptions are judgmental in nature and could have a significant impact on the determination of the debt component, and the associated non-cash interest expense. We assigned a value to the debt component of our convertible notes equal to the estimated fair value of similar debt instruments without the conversion feature, which resulted in us recording our debt at a discount. We are amortizing our debt issuance costs and debt discount over the life of the convertible notes as additional non-cash interest expense utilizing the effective interest method. |
Segment Information | Segment Information We have operating segments, our Ionis Core segment and Akcea Therapeutics, our majority-owned affiliate. Akcea is . We provide segment financial information and results for our Ionis Core segment and our Akcea Therapeutics segment based on the segregation of revenues and expenses that our chief decision maker reviews to assess operating performance and to make operating decisions. We allocate a portion of Ionis’ development, R&D support and general and administrative expenses to Akcea for work Ionis performs on behalf of Akcea. |
Stock-Based Compensation Expense | Stock-based Compensation Expense We measure stock-based compensation expense for equity-classified awards, principally related to stock options, restricted stock units, or RSUs, and stock purchase rights under our ESPP based on the estimated fair value of the award on the date of grant. We recognize the value of the portion of the award that we ultimately expect to vest as stock-based compensation expense over the requisite service period in our condensed consolidated statements of operations. We reduce stock-based compensation expense for estimated forfeitures at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. We use the Black-Scholes model to estimate the fair value of stock options granted and stock purchase rights under our ESPP. The expected term of stock options granted represents the period of time that we expect them to be outstanding. We estimate the expected term of options granted based on historical exercise patterns. For the nine months ended September 30, 2019 and 2018, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.3 % 2.3 % Dividend yield 0.0 % 0.0 % Volatility 60.3 % 63.1 % Expected life 4.6 years 4.6 years Ionis Board of Director Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 1.9 % 2.8 % Dividend yield 0.0 % 0.0 % Volatility 60.7 % 61.5 % Expected life 6.6 years 6.6 years Ionis ESPP: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.4 % 1.8 % Dividend yield 0.0 % 0.0 % Volatility 45.6 % 47.3 % Expected life 6 months 6 months Ionis RSU’s: The fair value of RSUs is based on the market price of our common stock on the date of grant. RSUs vest annually over a four-year period. The weighted-average grant date fair value of RSUs granted to employees for the nine months ended September 30, 2019 was $59.79 per share. The weighted-average grant date fair value of RSUs granted to our board of directors for the nine months ended September 30, 2019 was $64.65 per share. In addition to our stock plans, Akcea has its own stock plan under which it grants stock options and RSUs and under which it derives its stock-based compensation expense. The following are the weighted-average Black-Scholes assumptions Akcea used under its plan for the nine months ended September 30, 2019 and 2018 : Akcea Employee Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.3 % 2.7 % Dividend yield 0.0 % 0.0 % Volatility 75.6 % 77.1 % Expected life 6.1 years 6.1 years Akcea Board of Directors Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 1.8 % 2.9 % Dividend yield 0.0 % 0.0 % Volatility 73.8 % 78.2 % Expected life 6.3 years 6.4 years Akcea ESPP: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.4 % 1.9 % Dividend yield 0.0 % 0.0 % Volatility 60.0 % 64.2 % Expected life 6 months 6 months The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2019 and 2018 (in thousands). Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of products sold $ 127 $ — $ 383 $ — Research, development and patent 23,744 18,780 71,935 57,698 Selling, general and administrative 255 16,103 39,246 39,512 Total non-cash stock-based compensation expense $ 24,126 $ 34,883 $ 111,564 $ 97,210 In the third quarter of 2019, three Akcea executive officers terminated their employment and entered into separation agreements with Akcea. As a result, in the third quarter of 2019, Akcea reversed $19.1 million of stock-based compensation expense it had previously recognized related to the executive officers’ stock options and RSUs that were no longer going to vest. As of September 30, 2019, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $143.9 million and $71.3 million, respectively. Our actual expenses may differ from these estimates because we will adjust our unrecognized non-cash stock-based compensation expense for future forfeitures. We expect to recognize the cost of non-cash stock-based compensation expense related to non-vested stock options and RSUs over a weighted average amortization period of 1.2 years and 1.6 years, respectively. |
Impact of Recently Issued Accounting Standards | Impact of Recently Issued Accounting Standards In June 2016, the FASB issued guidance that changes the measurement of credit losses for most financial assets and certain other instruments. If we have credit losses, this updated guidance requires us to record allowances for these instruments under a new expected credit loss model. This model requires us to estimate the expected credit loss of an instrument over its lifetime, which represents the portion of the amortized cost basis we do not expect to collect. The new guidance requires us to remeasure our allowance in each reporting period we have credit losses. The new standard is effective for annual and interim periods beginning after December 15, 2019. Early adoption is permitted for periods beginning after December 15, 2018. When we adopt the new standard, we will make any adjustments to beginning balances through a cumulative-effect adjustment to accumulated deficit on that date. We plan to adopt this guidance on January 1, 2020. We do not anticipate this guidance will have a significant impact on our condensed consolidated financial statements and disclosures. In August 2018, the FASB issued clarifying guidance on how to account for implementation costs related to cloud-servicing arrangements. The guidance states that if these fees qualify to be capitalized and amortized over the service period, they need to be expensed in the same line item as the service expense and recognized in the same balance sheet category. The update can be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The updated guidance is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. We plan to adopt this guidance on January 1, 2020 on a prospective basis. We do not anticipate this guidance will have a significant impact on our condensed consolidated financial statements and disclosures. In August 2018, the FASB updated its disclosure requirements related to Level 1, 2 and 3 fair value measurements. The update included deletion and modification of certain disclosure requirements and additional disclosure related to Level 3 measurements. The guidance is effective for fiscal years beginning after December 31, 2019 and early adoption is permitted. We adopted this updated guidance on January 1, 2019 and it did not have a significant impact on our disclosures. In November 2018, the FASB issued clarifying guidance of the interaction between the collaboration accounting guidance and the new revenue recognition guidance we adopted on January 1, 2018 (Topic 606). Below is the clarifying guidance and how we will implement it (in italics): 1) When a participant is considered a customer in a collaborative arrangement, all of the associated accounting under Topic 606 should be applied ● We will apply all of the associated accounting under Topic 606 when we determine a participant in a collaborative arrangement is a customer 2) Adds “unit of account” concept to collaboration accounting guidance to align with Topic 606. The “unit of account” concept is used to determine if revenue is recognized or if a contra expense is recognized from consideration received under a collaboration ● We will use the “unit of account” concept when we receive consideration under a collaborative arrangement to determine when we recognize revenue or a contra expense 3) The clarifying guidance precludes us from recognizing revenue under Topic 606 when we determine a transaction with a collaborative partner is not a customer and is not directly related to the sales to third parties ● When we conclude a collaboration partner is not a customer and is not directly related to the sales to third parties, we will not recognize revenue for the transaction The updated guidance is effective for public entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. We plan to adopt this guidance on January 1, 2020. We are currently assessing the effects it could have on our condensed consolidated financial statements and disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Significant Accounting Policies [Abstract] | |
Basic Net Income (Loss) per Share | Our basic net income per share for the three months ended September 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 70,221 $ (0.34 ) $ (23,772 ) Akcea’s net loss attributable to our ownership $ (23,772 ) Ionis’ stand-alone net income 49,930 Net income available to Ionis common stockholders $ 26,158 Weighted average shares outstanding 140,551 Basic net income per share $ 0.19 Our basic net income per share for the nine months ended Nine months ended September 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 69,681 $ (0.40 ) $ (28,174 ) Akcea’s net loss attributable to our ownership $ (28,174 ) Ionis’ stand-alone net income 140,938 Net income available to Ionis common stockholders $ 112,764 Weighted average shares outstanding 139,800 Basic net income per share $ 0.81 Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts): Three months ended September 30, 2018 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 65,538 $ (0.73 ) $ (47,843 ) Akcea’s net loss attributable to our ownership $ (47,843 ) Ionis’ stand-alone net income 43,226 Net loss available to Ionis common stockholders $ (4,617 ) Weighted average shares outstanding 137,346 Basic net loss per share $ (0.03 ) Our basic net loss per share for the nine months ended Nine months ended September 30, 2018 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Ionis’ Portion of Akcea’s Net Loss Common shares 57,347 $ (1.93 ) $ (110,680 ) Akcea’s net loss attributable to our ownership $ (110,680 ) Ionis’ stand-alone net income 67,517 Net loss available to Ionis common stockholders $ (43,163 ) Weighted average shares outstanding 130,507 Basic net loss per share $ (0.33 ) |
Basic and Diluted Net Income Per Share | We calculated our diluted net income per share for the three months ended September 30, 2019 as follows (in thousands except per share amounts): Three months ended September 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 26,158 140,551 $ 0.19 Effect of dilutive securities: Shares issuable upon exercise of stock options — 1,993 Shares issuable upon restricted stock award issuance — 844 Shares issuable related to our Employee Stock Purchase Plan — 20 Income available to Ionis common stockholders $ 26,158 143,408 $ 0.18 We calculated our diluted net income per share for the nine months ended September 30, 2019 as follows (in thousands except per share amounts): Nine months ended September 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 112,764 139,800 $ 0.81 Effect of dilutive securities: Shares issuable upon exercise of stock options — 2,208 Shares issuable upon restricted stock award issuance — 793 Shares issuable related to our Employee Stock Purchase Plan — 20 Income available to Ionis common stockholders $ 112,764 142,821 $ 0.79 |
Significant Accounting Policies [Abstract] | |
Weighted-Average Assumptions for Stock Options | We use the Black-Scholes model to estimate the fair value of stock options granted and stock purchase rights under our ESPP. The expected term of stock options granted represents the period of time that we expect them to be outstanding. We estimate the expected term of options granted based on historical exercise patterns. For the nine months ended September 30, 2019 and 2018, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.3 % 2.3 % Dividend yield 0.0 % 0.0 % Volatility 60.3 % 63.1 % Expected life 4.6 years 4.6 years Ionis Board of Director Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 1.9 % 2.8 % Dividend yield 0.0 % 0.0 % Volatility 60.7 % 61.5 % Expected life 6.6 years 6.6 years |
Weighted-Average Assumptions for ESPP | Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.4 % 1.8 % Dividend yield 0.0 % 0.0 % Volatility 45.6 % 47.3 % Expected life 6 months 6 months |
Stock-Based Compensation Expense | The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2019 and 2018 (in thousands). Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of products sold $ 127 $ — $ 383 $ — Research, development and patent 23,744 18,780 71,935 57,698 Selling, general and administrative 255 16,103 39,246 39,512 Total non-cash stock-based compensation expense $ 24,126 $ 34,883 $ 111,564 $ 97,210 |
Akcea [Member] | |
Significant Accounting Policies [Abstract] | |
Weighted-Average Assumptions for Stock Options | The following are the weighted-average Black-Scholes assumptions Akcea used under its plan for the nine months ended September 30, 2019 and 2018 : Akcea Employee Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.3 % 2.7 % Dividend yield 0.0 % 0.0 % Volatility 75.6 % 77.1 % Expected life 6.1 years 6.1 years Akcea Board of Directors Stock Options: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 1.8 % 2.9 % Dividend yield 0.0 % 0.0 % Volatility 73.8 % 78.2 % Expected life 6.3 years 6.4 years |
Weighted-Average Assumptions for ESPP | Akcea ESPP: Nine Months Ended September 30, 2019 2018 Risk-free interest rate 2.4 % 1.9 % Dividend yield 0.0 % 0.0 % Volatility 60.0 % 64.2 % Expected life 6 months 6 months |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments [Abstract] | |
Contract Maturity of Available-for-Sale Securities | The following table summarizes the contract maturity of the available-for-sale securities we held as of September 30, 2019: One year or less 69 % After one year but within two years 22 % After two years but within three years 9 % Total 100 % |
Summary of Investments | The following is a summary of our investments (in thousands): Gross Unrealized Estimated September 30, 2019 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 752,495 $ 1,484 $ (148 ) $ 753,831 Debt securities issued by U.S. government agencies 176,589 321 (45 ) 176,865 Debt securities issued by the U.S. Treasury (2) 331,371 264 (17 ) 331,618 Debt securities issued by states of the U.S. and political subdivisions of the states 33,986 4 (27 ) 33,963 Other municipal debt securities 2,948 — — 2,948 Total securities with a maturity of one year or less 1,297,389 2,073 (237 ) 1,299,225 Corporate debt securities 539,820 3,108 (161 ) 542,767 Debt securities issued by U.S. government agencies 106,536 101 (137 ) 106,500 Debt securities issued by the U.S. Treasury 34,692 — (38 ) 34,654 Debt securities issued by states of the U.S. and political subdivisions of the states 9,283 25 (6 ) 9,302 Total securities with a maturity of more than one year 690,331 3,234 (342 ) 693,223 Total available-for-sale securities $ 1,987,720 $ 5,307 $ (579 ) $ 1,992,448 Equity securities: Total equity securities included in other current assets (3) $ 1,212 $ — $ (606 ) $ 606 Total available-for-sale and equity securities $ 1,988,932 $ 5,307 $ (1,185 ) $ 1,993,054 Gross Unrealized Estimated December 31, 2018 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities $ 956,879 $ 13 $ (1,858 ) $ 955,034 Debt securities issued by U.S. government agencies 168,839 3 (104 ) 168,738 Debt securities issued by the U.S. Treasury 244,640 15 (77 ) 244,578 Debt securities issued by states of the U.S. and political subdivisions of the states (2) 63,572 — (323 ) 63,249 Total securities with a maturity of one year or less 1,433,930 31 (2,362 ) 1,431,599 Corporate debt securities 299,018 194 (1,286 ) 297,926 Debt securities issued by U.S. government agencies 107,789 194 (109 ) 107,874 Debt securities issued by the U.S. Treasury 15,600 — (24 ) 15,576 Debt securities issued by states of the U.S. and political subdivisions of the states 16,980 — (287 ) 16,693 Total securities with a maturity of more than one year 439,387 388 (1,706 ) 438,069 Total available-for-sale securities $ 1,873,317 $ 419 $ (4,068 ) $ 1,869,668 Equity securities: Total equity securities included in other current assets (3) 1,212 137 — 1,349 Total available-for-sale and equity securities $ 1,874,529 $ 556 $ (4,068 ) $ 1,871,017 (1) Our available-for-sale securities are held at amortized cost. (2) Includes investments classified as cash equivalents on our condensed consolidated balance sheet. (3) We recognize our equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer on our condensed consolidated balance sheet. |
Temporarily Impaired Investments | The following is a summary of our investments we consider to be temporarily impaired at September 30, 2019. We believe that the decline in value of these securities is temporary and is primarily related to the change in market interest rates since purchase. We believe it is more likely than not that we will be able to hold our debt securities to maturity. Therefore, we anticipate full recovery of our debt securities’ amortized cost basis at maturity. Less than 12 Months of Temporary Impairment More than 12 Months of Temporary Impairment Total Temporary Impairment (In thousands) Number of Investments Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Corporate debt securities 104 $ 304,705 $ (268 ) $ 31,675 $ (41 ) $ 336,380 $ (309 ) Debt securities issued by U.S. government agencies 28 102,733 (156 ) 22,974 (26 ) 125,707 (182 ) Debt securities issued by the U.S. Treasury 9 77,918 (55 ) — — 77,918 (55 ) Debt securities issued by states of the U.S. and political subdivisions of the states 13 1,498 (1 ) 15,597 (32 ) 17,095 (33 ) Total temporarily impaired securities 154 $ 486,854 $ (480 ) $ 70,246 $ (99 ) $ 557,100 $ (579 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Measurements [Abstract] | |
Assets Measured at Fair Value on a Recurring Basis | The following tables present the major security types we held at and that we regularly measure and carry at fair value. At and , subject to trading restrictions that extend to the fourth quarter of 2019; as a result, we The amount we owned in ProQR did not change from to . The tables below segregate each security type by the level within the fair value hierarchy of the valuation techniques we utilized to determine the respective securities’ fair value (in thousands): At September 30, 2019 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 202,904 $ 202,904 $ — $ — Corporate debt securities (2) 1,296,598 — 1,296,598 — Debt securities issued by U.S. government agencies (3) 283,365 — 283,365 — Debt securities issued by the U.S. Treasury (4) 366,272 366,272 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 43,265 — 43,265 — Other municipal debt securities (3) 2,948 — 2,948 — Investment in ProQR Therapeutics N.V. (5) 606 — — 606 Total $ 2,195,958 $ 569,176 $ 1,626,176 $ 606 At December 31, 2018 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 146,281 $ 146,281 $ — $ — Corporate debt securities (6) 1,252,960 — 1,252,960 — Debt securities issued by U.S. government agencies (3) 276,612 — 276,612 — Debt securities issued by the U.S. Treasury (7) 260,154 260,154 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 79,942 — 79,942 — Investment in ProQR Therapeutics N.V. (5) 1,349 — — 1,349 Total $ 2,017,298 $ 406,435 $ 1,609,514 $ 1,349 The following footnotes reference lines on our condensed consolidated balance sheet: (1) Included in cash and cash equivalents. (2) $16.6 million was included in cash and cash equivalents, with the difference included in short-term investments. (3) Included in short-term investments. (4) $3.0 million was included in cash and cash equivalents, with the difference included in short-term investments. (5) Included in other current assets. (6) $50.2 million was included in cash and cash equivalents, with the difference included in short-term investments. (7) $14.2 million was included in cash and cash equivalents, with the difference included in short-term investments. |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Amounts Related to Operating Leases | Amounts related to our operating leases were as follows (dollar amounts in millions): At September 30, 2019 Right-of-use operating lease assets (1) $ 13.0 Operating lease liabilities (2) $ 17.7 Weighted average remaining lease term 8.3 years Weighted average discount rate 7.5 % (1) Included in deposits and other assets on our condensed consolidated balance sheet. (2) Current portion of $2.1 million was included in current portion of long-term obligations on our condensed consolidated balance sheet, with the difference included in long-term obligations. |
Future Minimum Payments Under Operating Leases | As of September 30, 2019, the payments for our operating lease liabilities are as follows (in thousands): Operating Leases Remainder of 2019 $ 801 Years ending December 31, 2020 3,282 2021 3,019 2022 2,781 2023 2,520 Thereafter 11,861 Total minimum lease payments 24,264 Less: Imputed interest (6,533 ) Total operating lease liabilities $ 17,731 |
Collaborative Arrangements an_2
Collaborative Arrangements and Licensing Agreements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Biogen [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 SPINRAZA royalties (commercial revenue) $ 81.7 $ 70.0 $ 211.9 $ 167.7 R&D revenue 25.5 34.8 81.9 66.9 Total revenue from our relationship with Biogen $ 107.2 $ 104.8 $ 293.8 $ 234.6 Percentage of total revenue 64 % 72 % 47 % 58 % |
GSK [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with GSK (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 25.1 $ 0.1 $ 25.3 $ 1.5 Percentage of total revenue 15 % 0 % 4 % 0 % |
Roche [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 4.7 $ 1.8 $ 52.3 $ 5.4 Percentage of total revenue 3 % 1 % 8 % 1 % |
Novartis [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2019 and 2018, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 R&D revenue $ 8.5 $ 7.2 $ 176.3 $ 42.7 Percentage of total revenue 5 % 5 % 28 % 10 % |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Segment Information [Abstract] | |
Segment Information | The following tables show our segment revenue and income (loss) from operations for the three and nine months ended September 30, 2019 and 2018 (in thousands), respectively. Three Months Ended September 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 81,672 $ — $ — $ 81,672 Product sales, net — 11,945 — 11,945 Licensing and other royalty revenue 1,946 136 — 2,082 Total commercial revenue 83,618 12,081 — 95,699 R&D revenue under collaborative agreements 69,165 8,543 (5,515 ) 72,193 Total segment revenue $ 152,783 $ 20,624 $ (5,515 ) $ 167,892 Total operating expenses $ 119,147 $ 53,215 $ (6,993 ) $ 165,369 Income (loss) from operations $ 33,636 $ (32,591 ) $ 1,478 $ 2,523 Three Months Ended September 30, 2018 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 70,010 $ — $ — $ 70,010 Licensing and other royalty revenue 7,946 12,000 (7,200 ) 12,746 Total commercial revenue 77,956 12,000 (7,200 ) 82,756 R&D revenue under collaborative agreements 100,105 7,241 (44,707 ) 62,639 Total segment revenue $ 178,061 $ 19,241 $ (51,907 ) $ 145,395 Total operating expenses $ 87,664 $ 84,249 $ (7,946 ) $ 163,967 Income (loss) from operations $ 90,397 $ (65,008 ) $ (43,961 ) $ (18,572 ) Nine Months Ended September 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 211,884 $ — $ — $ 211,884 Product sales, net — 28,563 — 28,563 Licensing and other royalty revenue 8,466 6,172 (3,000 ) 11,638 Total commercial revenue 220,350 34,735 (3,000 ) 252,085 R&D revenue under collaborative agreements 294,512 176,328 (94,007 ) 376,833 Total segment revenue $ 514,862 $ 211,063 $ (97,007 ) $ 628,918 Total operating expenses $ 355,437 $ 256,152 $ (87,900 ) $ 523,689 Income (loss) from operations $ 159,425 $ (45,089 ) $ (9,107 ) $ 105,229 Nine Months Ended September 30, 2018 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 167,743 $ — $ — $ 167,743 Licensing and other royalty revenue 9,432 12,000 (7,200 ) 14,232 Total commercial revenue 177,175 12,000 (7,200 ) 181,975 R&D revenue under collaborative agreements 232,850 42,670 (49,936 ) 225,584 Total segment revenue $ 410,025 $ 54,670 $ (57,136 ) $ 407,559 Total operating expenses $ 279,084 $ 213,428 $ (12,796 ) $ 479,716 Income (loss) from operations $ 130,941 $ (158,758 ) $ (44,340 ) $ (72,157 ) The following table shows our total assets by segment at September 30, 2019 and December 31, 2018 (in thousands), respectively. Total Assets Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total September 30, 2019 $ 3,233,175 $ 383,167 $ (721,353 ) $ 2,894,989 December 31, 2018 $ 2,975,491 $ 365,261 $ (672,968 ) $ 2,667,784 |
Basis of Presentation (Details)
Basis of Presentation (Details) - Akcea [Member] - shares shares in Millions | 3 Months Ended | ||||||
Dec. 31, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Apr. 30, 2018 | Jul. 31, 2017 | Jun. 30, 2017 | |
Basis of Presentation [Abstract] | |||||||
Percentage ownership | 76.00% | 75.00% | 75.00% | 68.00% | 68.00% | 100.00% | |
Additional shares of Akcea stock received (in shares) | 2.8 | ||||||
Forecast [Member] | |||||||
Basis of Presentation [Abstract] | |||||||
Additional shares of Akcea stock received (in shares) | 6.9 |
Significant Accounting Polici_4
Significant Accounting Policies, Revenue Recognition (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Feb. 28, 2017USD ($)PerformanceObligation | May 31, 2015USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018Agreement | Sep. 30, 2019USD ($)PerformanceObligation | Sep. 30, 2018USD ($) | |
Revenue Recognition [Abstract] | ||||||||||
Number of performance obligations at inception of contract | PerformanceObligation | 1 | |||||||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | ||||||
Biogen [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Number of agreements | Agreement | 2 | |||||||||
Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | 2,082 | $ 12,746 | $ 11,638 | $ 14,232 | ||||||
Roche [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 35,000 | |||||||||
IONIS-FB-L for Complement-Mediated Diseases [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Upfront payment received | $ 75,000 | |||||||||
2018 Strategic Neurology [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Milestone payment earned and amortized over period of performance | $ 7,500 | |||||||||
2013 Strategic Neurology [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | (16,500) | |||||||||
2013 Strategic Neurology [Member] | IONIS-LRRK2 [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | 8,000 | |||||||||
GSK [Member] | Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 25,000 | |||||||||
Alnylam [Member] | Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 20,000 | |||||||||
Bayer [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Number of separate performance obligations | PerformanceObligation | 3 | |||||||||
Bayer [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Upfront payment received | $ 100,000 | |||||||||
Bayer [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Upfront payment received | $ 75,000 | |||||||||
Transaction price | $ 75,000 |
Significant Accounting Polici_5
Significant Accounting Policies, Contracts Receivable (Details) | 9 Months Ended |
Sep. 30, 2019 | |
Contracts Receivable [Abstract] | |
Period of time after billing when payment is received | 3 months |
Significant Accounting Polici_6
Significant Accounting Policies, Deferred Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Deferred Revenue [Abstract] | ||||
Revenue recognized from amounts in beginning deferred revenue balance | $ 30.3 | $ 37.2 | $ 103.5 | $ 80.4 |
Significant Accounting Polici_7
Significant Accounting Policies, Cost of Products Sold (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Cost of Products Sold [Abstract] | ||
Previously expensed costs to produce TEGSEDI related to TEGSEDI commercial revenue | $ 0.2 | $ 0.5 |
Significant Accounting Polici_8
Significant Accounting Policies, Noncontrolling Interest in Akcea (Details) - Akcea [Member] - shares shares in Millions | 3 Months Ended | ||||||
Dec. 31, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Apr. 30, 2018 | Jul. 31, 2017 | Jun. 30, 2017 | |
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | |||||||
Percentage ownership | 76.00% | 75.00% | 75.00% | 68.00% | 68.00% | 100.00% | |
Additional shares of Akcea stock received (in shares) | 2.8 | ||||||
Forecast [Member] | |||||||
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | |||||||
Additional shares of Akcea stock received (in shares) | 6.9 |
Significant Accounting Polici_9
Significant Accounting Policies, Cash, Cash Equivalents and Investments (Details) | Sep. 30, 2019Company |
Cash, Cash Equivalents and Investments [Abstract] | |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 2 |
Number of privately-held companies in which there is an equity ownership interest of less than 20% | 4 |
Significant Accounting Polic_10
Significant Accounting Policies, Inventory Valuation (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Inventory Valuation [Abstract] | ||
Inventory write-off | $ 0 | |
Inventories | $ 19,375 | $ 8,582 |
Significant Accounting Polic_11
Significant Accounting Policies, Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | |
Operating Leases [Abstract] | |||
Right-of-use operating lease assets | [1] | $ 13,000 | |
Operating lease liabilities | [2] | 17,731 | |
Current portion of operating lease liabilties | $ 2,100 | ||
Topic 842 [Member] | |||
Operating Leases [Abstract] | |||
Right-of-use operating lease assets | $ 13,500 | ||
Operating lease liabilities | 18,500 | ||
Current portion of operating lease liabilties | $ 2,000 | ||
[1] | Included in deposits and other assets on our condensed consolidated balance sheet. | ||
[2] | Current portion of $2.1 million was included in current portion of long-term obligations on our condensed consolidated balance sheet, with the difference included in long-term obligations. |
Significant Accounting Polic_12
Significant Accounting Policies, Basic and Diluted Net Income (Loss) per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Basic Net Income (Loss) per Share [Abstract] | |||||
Basic net income (loss) per share (in dollars per share) | $ 0.19 | $ (0.03) | $ 0.81 | $ (0.33) | |
Net income (loss) | $ 26,163 | $ (4,559) | $ 109,730 | $ (46,335) | |
Net income (loss) available to Ionis common shareholders | $ 26,158 | $ (4,617) | $ 112,764 | $ (43,163) | |
Weighted average shares outstanding (in shares) | 140,551 | 137,346 | 139,800 | 130,507 | |
Income available to Ionis common shareholders | $ 26,158 | $ 112,764 | |||
Shares issuable related to our Employee Stock Purchase Plan (in shares) | 20 | 20 | |||
Shares used in computing diluted net income per share (in shares) | 143,408 | 137,346 | 142,821 | 130,507 | |
Diluted net income per share (in dollars per share) | $ 0.18 | $ (0.03) | $ 0.79 | $ (0.33) | |
1 Percent Convertible Senior Notes [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% | 1.00% | 1.00% |
Stock Options [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Shares issuable related to stock-based compensation (in shares) | 1,993 | 2,208 | |||
Restricted Stock Awards [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Shares issuable related to stock-based compensation (in shares) | 844 | 793 | |||
Ionis [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Net income (loss) | $ 49,930 | $ 43,226 | $ 140,938 | $ 67,517 | |
Akcea [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Net income (loss) | $ (23,772) | $ (47,843) | $ (28,174) | $ (110,680) | |
Akcea [Member] | Common Stock [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Weighted average shares owned in Akcea (in shares) | 70,221 | 65,538 | 69,681 | 57,347 | |
Basic net income (loss) per share (in dollars per share) | $ (0.34) | $ (0.73) | $ (0.40) | $ (1.93) | |
Net income (loss) | $ (23,772) | $ (47,843) | $ (28,174) | $ (110,680) |
Significant Accounting Polic_13
Significant Accounting Policies, Segment Information (Details) | 9 Months Ended |
Sep. 30, 2019Segment | |
Segment Information [Abstract] | |
Number of operating segments | 2 |
Significant Accounting Polic_14
Significant Accounting Policies, Stock-Based Compensation Expense (Details) $ / shares in Units, $ in Thousands, shares in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019USD ($)Officer | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)$ / shares | Sep. 30, 2018USD ($) | Jun. 30, 2019shares | May 31, 2019shares | |
Stock-based Compensation Expense [Abstract] | ||||||
Number of executive officers terminating employment | Officer | 3 | |||||
Stock-based compensation expense | $ 24,126 | $ 34,883 | $ 111,564 | $ 97,210 | ||
Employee Stock Options [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 2.30% | 2.30% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 60.30% | 63.10% | ||||
Expected life | 4 years 7 months 6 days | 4 years 7 months 6 days | ||||
Unrecognized Compensation Expense [Abstract] | ||||||
Unrecognized compensation expense related to non-vested stock options | 143,900 | $ 143,900 | ||||
Weighted average period for recognition | 1 year 2 months 12 days | |||||
Board of Director Stock Options [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 1.90% | 2.80% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 60.70% | 61.50% | ||||
Expected life | 6 years 7 months 6 days | 6 years 7 months 6 days | ||||
ESPP [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 2.40% | 1.80% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 45.60% | 47.30% | ||||
Expected life | 6 months | 6 months | ||||
RSUs [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Vesting period | 4 years | |||||
Unrecognized Compensation Expense [Abstract] | ||||||
Unrecognized compensation cost related to non-vested RSUs | 71,300 | $ 71,300 | ||||
Weighted average period for recognition | 1 year 7 months 6 days | |||||
RSUs [Member] | Employees [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 59.79 | |||||
RSUs [Member] | Board of Directors [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 64.65 | |||||
2011 Equity Incentive Plan [Member] | ||||||
Amendment to Equity Plan [Abstract] | ||||||
Common shares reserved for future issuance (in shares) | shares | 23 | 16 | ||||
Cost of Products Sold [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Stock-based compensation expense | 127 | 0 | $ 383 | $ 0 | ||
Research, Development and Patent [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Stock-based compensation expense | 23,744 | 18,780 | 71,935 | 57,698 | ||
Selling, General and Administrative [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Stock-based compensation expense | 255 | $ 16,103 | $ 39,246 | $ 39,512 | ||
Akcea [Member] | ||||||
Stock-based Compensation Expense [Abstract] | ||||||
Stock-based compensation expense | $ (19,100) | |||||
Akcea [Member] | Employee Stock Options [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 2.30% | 2.70% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 75.60% | 77.10% | ||||
Expected life | 6 years 1 month 6 days | 6 years 1 month 6 days | ||||
Akcea [Member] | Board of Director Stock Options [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 1.80% | 2.90% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 73.80% | 78.20% | ||||
Expected life | 6 years 3 months 18 days | 6 years 4 months 24 days | ||||
Akcea [Member] | ESPP [Member] | ||||||
Weighted-Average Assumptions [Abstract] | ||||||
Risk-free interest rate | 2.40% | 1.90% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 60.00% | 64.20% | ||||
Expected life | 6 months | 6 months |
Significant Accounting Polic_15
Significant Accounting Policies, Share Repurchase Program (Details) $ in Millions | 1 Months Ended |
Sep. 30, 2019USD ($)shares | |
Significant Accounting Policies [Abstract] | |
Authorized amount of share repurchase program | $ | $ 125 |
Shares repurchased (in shares) | shares | 0 |
Investments, Contract Maturity
Investments, Contract Maturity of Available-for-Sale Securities (Details) | 9 Months Ended |
Sep. 30, 2019Company | |
Contract Maturity of Available-for-Sale Securities [Abstract] | |
One year or less | 69.00% |
After one year but within two years | 22.00% |
After two years but within three years | 9.00% |
Total | 100.00% |
Percentage of available-for-sale securities with a maturity of less than two years | 91.00% |
Maximum contract maturity period, range 1 | 1 year |
Maximum contract maturity period, range 2 | 2 years |
Maximum contract maturity period, range 3 | 3 years |
Ownership Interests in Private and Public Companies [Abstract] | |
Number of privately-held companies in which there is an equity ownership interest of less than 20% | 4 |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 2 |
Investments, Summary of Investm
Investments, Summary of Investments (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | ||||
Summary of Investments [Abstract] | |||||
Cost | [1] | $ 1,212 | $ 1,212 | ||
Gross unrealized gains | 0 | 137 | |||
Gross unrealized losses | (606) | 0 | |||
Estimated fair value | 606 | 1,349 | |||
Cost | 1,988,932 | 1,874,529 | |||
Gross unrealized gains | 5,307 | 556 | |||
Gross unrealized losses | (1,185) | (4,068) | |||
Estimated fair value | 1,993,054 | 1,871,017 | |||
Available-for-sale Securities [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 1,987,720 | 1,873,317 | ||
Gross unrealized gains | 5,307 | 419 | |||
Gross unrealized losses | (579) | (4,068) | |||
Estimated fair value | 1,992,448 | 1,869,668 | |||
Available-for-sale Securities [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 1,297,389 | 1,433,930 | ||
Gross unrealized gains | 2,073 | 31 | |||
Gross unrealized losses | (237) | (2,362) | |||
Estimated fair value | 1,299,225 | 1,431,599 | |||
Available-for-sale Securities [Member] | Securities with Maturity of More than One Year [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 690,331 | 439,387 | ||
Gross unrealized gains | 3,234 | 388 | |||
Gross unrealized losses | (342) | (1,706) | |||
Estimated fair value | 693,223 | 438,069 | |||
Corporate Debt Securities [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 752,495 | [3] | 956,879 | |
Gross unrealized gains | 1,484 | 13 | |||
Gross unrealized losses | (148) | (1,858) | |||
Estimated fair value | 753,831 | 955,034 | |||
Corporate Debt Securities [Member] | Securities with Maturity of More than One Year [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 539,820 | 299,018 | ||
Gross unrealized gains | 3,108 | 194 | |||
Gross unrealized losses | (161) | (1,286) | |||
Estimated fair value | 542,767 | 297,926 | |||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 176,589 | 168,839 | ||
Gross unrealized gains | 321 | 3 | |||
Gross unrealized losses | (45) | (104) | |||
Estimated fair value | 176,865 | 168,738 | |||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of More than One Year [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 106,536 | 107,789 | ||
Gross unrealized gains | 101 | 194 | |||
Gross unrealized losses | (137) | (109) | |||
Estimated fair value | 106,500 | 107,874 | |||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 331,371 | [3] | 244,640 | |
Gross unrealized gains | 264 | 15 | |||
Gross unrealized losses | (17) | (77) | |||
Estimated fair value | 331,618 | 244,578 | |||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of More than One Year [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 34,692 | 15,600 | ||
Gross unrealized gains | 0 | 0 | |||
Gross unrealized losses | (38) | (24) | |||
Estimated fair value | 34,654 | 15,576 | |||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 33,986 | 63,572 | [3] | |
Gross unrealized gains | 4 | 0 | |||
Gross unrealized losses | (27) | (323) | |||
Estimated fair value | 33,963 | 63,249 | |||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of More than One Year [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 9,283 | 16,980 | ||
Gross unrealized gains | 25 | 0 | |||
Gross unrealized losses | (6) | (287) | |||
Estimated fair value | 9,302 | $ 16,693 | |||
Other Municipal Debt Securities [Member] | Securities with Maturity of One Year or Less [Member] | |||||
Summary of Investments [Abstract] | |||||
Cost | [2] | 2,948 | |||
Gross unrealized gains | 0 | ||||
Gross unrealized losses | 0 | ||||
Estimated fair value | $ 2,948 | ||||
[1] | We recognize our equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer on our condensed consolidated balance sheet. | ||||
[2] | Our available-for-sale securities are held at amortized cost. | ||||
[3] | Includes investments classified as cash equivalents on our condensed consolidated balance sheet. |
Investments, Investments Tempor
Investments, Investments Temporarily Impaired (Details) $ in Thousands | Sep. 30, 2019USD ($)Investment |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 154 |
Estimated fair value, less than 12 months of temporary impairment | $ 486,854 |
Unrealized losses, less than 12 months of temporary impairment | (480) |
Estimated fair value, more than 12 months of temporary impairment | 70,246 |
Unrealized losses, more than 12 months of temporary impairment | (99) |
Estimated fair value, total temporary impairment | 557,100 |
Unrealized losses, total temporary impairment | $ (579) |
Corporate Debt Securities [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 104 |
Estimated fair value, less than 12 months of temporary impairment | $ 304,705 |
Unrealized losses, less than 12 months of temporary impairment | (268) |
Estimated fair value, more than 12 months of temporary impairment | 31,675 |
Unrealized losses, more than 12 months of temporary impairment | (41) |
Estimated fair value, total temporary impairment | 336,380 |
Unrealized losses, total temporary impairment | $ (309) |
Debt Securities issued by U.S. Government Agencies [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 28 |
Estimated fair value, less than 12 months of temporary impairment | $ 102,733 |
Unrealized losses, less than 12 months of temporary impairment | (156) |
Estimated fair value, more than 12 months of temporary impairment | 22,974 |
Unrealized losses, more than 12 months of temporary impairment | (26) |
Estimated fair value, total temporary impairment | 125,707 |
Unrealized losses, total temporary impairment | $ (182) |
Debt Securities issued by the U.S. Treasury [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 9 |
Estimated fair value, less than 12 months of temporary impairment | $ 77,918 |
Unrealized losses, less than 12 months of temporary impairment | (55) |
Estimated fair value, more than 12 months of temporary impairment | 0 |
Unrealized losses, more than 12 months of temporary impairment | 0 |
Estimated fair value, total temporary impairment | 77,918 |
Unrealized losses, total temporary impairment | $ (55) |
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 13 |
Estimated fair value, less than 12 months of temporary impairment | $ 1,498 |
Unrealized losses, less than 12 months of temporary impairment | (1) |
Estimated fair value, more than 12 months of temporary impairment | 15,597 |
Unrealized losses, more than 12 months of temporary impairment | (32) |
Estimated fair value, total temporary impairment | 17,095 |
Unrealized losses, total temporary impairment | $ (33) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | |||
Fair Value Measurements [Abstract] | ||||||
Investment in ProQR Therapeutics N.V. | $ 606 | $ 1,349 | ||||
1 Percent Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% | |||
Significant Other Observable Inputs (Level 2) [Member] | 1 Percent Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Fair value of convertible notes | $ 783,700 | |||||
Recurring Basis [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | [1] | 202,904 | $ 146,281 | |||
Investment in ProQR Therapeutics N.V. | [2] | 606 | 1,349 | |||
Total | 2,195,958 | 2,017,298 | ||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 1,296,598 | [3] | 1,252,960 | [4] | ||
Recurring Basis [Member] | Corporate Debt Securities [Member] | Cash and Cash Equivalents [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 16,600 | 50,200 | ||||
Recurring Basis [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | [5] | 283,365 | 276,612 | |||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 366,272 | [6] | 260,154 | [7] | ||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | Cash and Cash Equivalents [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 3,000 | 14,200 | ||||
Recurring Basis [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | [5] | 43,265 | 79,942 | |||
Recurring Basis [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | [5] | 2,948 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | 202,904 | 146,281 | ||||
Investment in ProQR Therapeutics N.V. | 0 | 0 | ||||
Total | 569,176 | 406,435 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 366,272 | 260,154 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | |||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | 0 | 0 | ||||
Investment in ProQR Therapeutics N.V. | 0 | 0 | ||||
Total | 1,626,176 | 1,609,514 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 1,296,598 | [3] | 1,252,960 | |||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 283,365 | 276,612 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 43,265 | 79,942 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 2,948 | |||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | 0 | 0 | ||||
Investment in ProQR Therapeutics N.V. | 606 | 1,349 | ||||
Total | 606 | 1,349 | ||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | 0 | ||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 0 | $ 0 | ||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | $ 0 | |||||
[1] | Included in cash and cash equivalents. | |||||
[2] | Included in other current assets. | |||||
[3] | $16.6 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[4] | $50.2 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[5] | Included in short-term investments. | |||||
[6] | $3.0 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[7] | $14.2 million was included in cash and cash equivalents, with the difference included in short-term investments. |
Operating Leases (Details)
Operating Leases (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)Option | Sep. 30, 2018USD ($) | ||
Operating Leases [Abstract] | |||||
Right-of-use operating lease assets | [1] | $ 13,000 | $ 13,000 | ||
Operating lease liabilities | [2] | $ 17,731 | $ 17,731 | ||
Weighted average remaining lease term | 8 years 3 months 18 days | 8 years 3 months 18 days | |||
Weighted average discount rate | 7.50% | 7.50% | |||
Current portion of operating lease liabilties | $ 2,100 | $ 2,100 | |||
Operating lease cash payments | 2,900 | ||||
Annual Future Minimum Payments Under Operating Leases [Abstract] | |||||
Remainder of 2019 | 801 | 801 | |||
2020 | 3,282 | 3,282 | |||
2021 | 3,019 | 3,019 | |||
2022 | 2,781 | 2,781 | |||
2023 | 2,520 | 2,520 | |||
Thereafter | 11,861 | 11,861 | |||
Total minimum lease payments | 24,264 | 24,264 | |||
Imputed interest | (6,533) | (6,533) | |||
Total operating lease liabilities | [2] | 17,731 | 17,731 | ||
Rent expense | $ 800 | $ 1,000 | $ 2,700 | $ 1,800 | |
Office and Laboratory Space Adjacent to Manufacturing Facility [Member] | |||||
Operating Leases [Abstract] | |||||
Number of options to extend lease | Option | 2 | ||||
Term of lease extension | 5 years | 5 years | |||
Office Space Subleased to Akcea [Member] | |||||
Operating Leases [Abstract] | |||||
Number of options to extend lease | Option | 1 | ||||
Term of lease extension | 5 years | 5 years | |||
Akcea [Member] | Office Space for Corporate Headquarters [Member] | |||||
Operating Leases [Abstract] | |||||
Term of lease extension | 5 years | 5 years | |||
Term of lease | 123 months | 123 months | |||
Period of free rent under lease | 3 months | ||||
Tenant improvement allowance | $ 3,800 | $ 3,800 | |||
Initial amount of letter of credit | 2,400 | 2,400 | |||
Letter of credit on third anniversary of rent commencement date | 1,800 | 1,800 | |||
Letter of credit on fifth anniversary of rent commencement date | $ 1,200 | $ 1,200 | |||
[1] | Included in deposits and other assets on our condensed consolidated balance sheet. | ||||
[2] | Current portion of $2.1 million was included in current portion of long-term obligations on our condensed consolidated balance sheet, with the difference included in long-term obligations. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Taxes [Abstract] | ||||
Income tax expense (benefit) | $ (14,915) | $ 452 | $ 9,204 | $ 824 |
Collaborative Arrangements an_3
Collaborative Arrangements and Licensing Agreements, Biogen (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2019USD ($)Medicine | Jun. 30, 2019USD ($)TargetPayment | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Sep. 30, 2019USD ($)Medicine | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | |||
SPINRAZA Royalties [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | 81,672 | 70,010 | 211,884 | 167,743 | |||
R&D Revenue [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | $ 72,193 | 62,639 | $ 376,833 | 225,584 | |||
Biogen [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Number of medicines currently in development under collaborations | Medicine | 8 | 8 | |||||
Cumulative payments received | $ 2,300,000 | $ 2,300,000 | |||||
Revenue | 107,200 | $ 104,800 | 293,800 | $ 234,600 | |||
Deferred revenue | $ 532,400 | $ 532,400 | $ 580,900 | ||||
Biogen [Member] | Revenue [Member] | Strategic Partner [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Concentration percentage | 64.00% | 72.00% | 47.00% | 58.00% | |||
Biogen [Member] | SPINRAZA Royalties [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | $ 81,700 | $ 70,000 | $ 211,900 | $ 167,700 | |||
Biogen [Member] | R&D Revenue [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | 25,500 | $ 34,800 | 81,900 | $ 66,900 | |||
2018 Strategic Neurology [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Upfront payment received | $ 1,000,000 | ||||||
Number of milestone payments achieved | Payment | 2 | ||||||
Milestone payment received | $ 7,500 | ||||||
Number of new targets advanced | Target | 2 | ||||||
Next prospective milestone | 7,500 | 7,500 | |||||
2018 Strategic Neurology [Member] | R&D Services [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Payments included in transaction price for performance obligation | 582,000 | 582,000 | |||||
2013 Strategic Neurology [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | (16,500) | ||||||
Payments included in transaction price for performance obligation | 145,000 | 145,000 | |||||
2013 Strategic Neurology [Member] | IONIS-LRRK2 [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | 8,000 | ||||||
2012 Neurology [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Revenue | 6,300 | ||||||
Milestone payment received | $ 7,500 | ||||||
Next prospective milestone | 10,000 | 10,000 | |||||
2012 Neurology [Member] | R&D Services [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Payments included in transaction price for performance obligation | 40,000 | 40,000 | |||||
2012 Neurology [Member] | IONIS-MAPT [Member] | |||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||
Payments included in transaction price for performance obligation | $ 25,500 | $ 25,500 |
Collaborative Arrangements an_4
Collaborative Arrangements and Licensing Agreements, Bayer (Details) - Bayer [Member] - USD ($) $ in Millions | 1 Months Ended | |
Oct. 31, 2019 | Sep. 30, 2019 | |
Collaborative Arrangement and Licensing Agreement [Abstract] | ||
Cumulative payments received | $ 175 | |
Next prospective milestone | $ 20 | |
Subsequent Event [Member] | ||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||
Milestone payment earned | $ 10 |
Collaborative Arrangements an_5
Collaborative Arrangements and Licensing Agreements, GSK (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019USD ($)Drug | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)Drug | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | |
R&D Revenue [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 72,193 | $ 62,639 | $ 376,833 | $ 225,584 | |
GSK [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Number of drugs being advanced | Drug | 2 | 2 | |||
Next prospective milestone | $ 15,000 | $ 15,000 | |||
Deferred revenue | $ 0 | $ 0 | $ 0 | ||
GSK [Member] | Revenue [Member] | Strategic Partner [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Concentration percentage | 15.00% | 0.00% | 4.00% | 0.00% | |
GSK [Member] | Minimum [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Cumulative payments received | $ 164,000 | $ 164,000 | |||
GSK [Member] | License Fees [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | 25,000 | ||||
GSK [Member] | R&D Revenue [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 25,100 | $ 100 | $ 25,300 | $ 1,500 |
Collaborative Arrangements an_6
Collaborative Arrangements and Licensing Agreements, Roche (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019USD ($)Agreement | Mar. 31, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)Agreement | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | ||
R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 72,193 | $ 62,639 | $ 376,833 | $ 225,584 | ||
Roche [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 2 | 2 | ||||
Deferred revenue | $ 56,700 | $ 56,700 | $ 72,600 | |||
Roche [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Concentration percentage | 3.00% | 1.00% | 8.00% | 1.00% | ||
Roche [Member] | R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 4,700 | $ 1,800 | $ 52,300 | $ 5,400 | ||
Huntington's Disease [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 1 | 1 | ||||
Cumulative payments received | $ 220,000 | $ 220,000 | ||||
Next prospective milestone | $ 15,000 | $ 15,000 | ||||
Revenue | $ 35,000 | |||||
IONIS-FB-L for Complement-Mediated Diseases [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 1 | 1 |
Collaborative Arrangements an_7
Collaborative Arrangements and Licensing Agreements, Novartis (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | ||
R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | 72,193 | $ 62,639 | 376,833 | $ 225,584 | ||
Novartis [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Deferred revenue | $ 10,800 | $ 10,800 | $ 28,800 | |||
Novartis [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Concentration percentage | 5.00% | 5.00% | 28.00% | 10.00% | ||
Novartis [Member] | Minimum [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Cumulative payments received | $ 343,000 | $ 343,000 | ||||
Novartis [Member] | AKCEA-APO(a)-L [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | 5,500 | $ 150,000 | ||||
Novartis [Member] | R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 8,500 | $ 7,200 | $ 176,300 | $ 42,700 | ||
Akcea [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Sublicense fee paid in stock | $ 75,000 | |||||
Additional shares of Akcea stock received (in shares) | 2.8 |
Collaborative Arrangements an_8
Collaborative Arrangements and Licensing Agreements, Pfizer (Details) - Akcea [Member] - USD ($) shares in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | |
Oct. 31, 2019 | Dec. 31, 2019 | Mar. 31, 2019 | |
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Sublicense fee paid for license of drug | $ 75 | ||
Additional shares of Akcea stock received (in shares) | 2.8 | ||
Pfizer [Member] | Forecast [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Sublicense fee paid for license of drug | $ 125 | ||
Additional shares of Akcea stock received (in shares) | 6.9 | ||
Pfizer [Member] | Subsequent Event [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Upfront license fee to be received | $ 250 | ||
Maximum amount of payments receivable for development, regulatory and sales milestones | $ 1,300 | ||
Royalty percentage received on net sales of drug | 20.00% |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)Segment | Sep. 30, 2018USD ($) | Mar. 31, 2019 | Dec. 31, 2018USD ($) | Apr. 30, 2018 | Jul. 31, 2017 | Jun. 30, 2017 | |
Segment Information [Abstract] | |||||||||
Number of reportable segments | Segment | 2 | ||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 167,892 | $ 145,395 | $ 628,918 | $ 407,559 | |||||
Total operating expenses | 165,369 | 163,967 | 523,689 | 479,716 | |||||
Income (loss) from operations | 2,523 | (18,572) | 105,229 | (72,157) | |||||
Total assets as of current period | 2,894,989 | 2,894,989 | $ 2,667,784 | ||||||
Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 95,699 | 82,756 | 252,085 | 181,975 | |||||
SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 81,672 | 70,010 | 211,884 | 167,743 | |||||
Product Sales, Net [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 11,945 | 0 | 28,563 | 0 | |||||
Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 2,082 | 12,746 | 11,638 | 14,232 | |||||
R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 72,193 | 62,639 | $ 376,833 | 225,584 | |||||
Akcea [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Percentage ownership | 75.00% | 75.00% | 76.00% | 75.00% | 68.00% | 68.00% | 100.00% | ||
Operating Segments [Member] | Ionis Core [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 152,783 | 178,061 | $ 514,862 | 410,025 | |||||
Total operating expenses | 119,147 | 87,664 | 355,437 | 279,084 | |||||
Income (loss) from operations | 33,636 | 90,397 | 159,425 | 130,941 | |||||
Total assets as of current period | 3,233,175 | 3,233,175 | $ 2,975,491 | ||||||
Operating Segments [Member] | Ionis Core [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 83,618 | 77,956 | 220,350 | 177,175 | |||||
Operating Segments [Member] | Ionis Core [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 81,672 | 70,010 | 211,884 | 167,743 | |||||
Operating Segments [Member] | Ionis Core [Member] | Product Sales, Net [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | |||||||
Operating Segments [Member] | Ionis Core [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 1,946 | 7,946 | 8,466 | 9,432 | |||||
Operating Segments [Member] | Ionis Core [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 69,165 | 100,105 | 294,512 | 232,850 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 20,624 | 19,241 | 211,063 | 54,670 | |||||
Total operating expenses | 53,215 | 84,249 | 256,152 | 213,428 | |||||
Income (loss) from operations | (32,591) | (65,008) | (45,089) | (158,758) | |||||
Total assets as of current period | 383,167 | 383,167 | 365,261 | ||||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 12,081 | 12,000 | 34,735 | 12,000 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | 0 | 0 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Product Sales, Net [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 11,945 | 28,563 | |||||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 136 | 12,000 | 6,172 | 12,000 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 8,543 | 7,241 | 176,328 | 42,670 | |||||
Elimination of Intercompany Activity [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | (5,515) | (51,907) | (97,007) | (57,136) | |||||
Total operating expenses | (6,993) | (7,946) | (87,900) | (12,796) | |||||
Income (loss) from operations | 1,478 | (43,961) | (9,107) | (44,340) | |||||
Total assets as of current period | (721,353) | (721,353) | $ (672,968) | ||||||
Elimination of Intercompany Activity [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | (7,200) | (3,000) | (7,200) | |||||
Elimination of Intercompany Activity [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | 0 | 0 | |||||
Elimination of Intercompany Activity [Member] | Product Sales, Net [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | |||||||
Elimination of Intercompany Activity [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | (7,200) | (3,000) | (7,200) | |||||
Elimination of Intercompany Activity [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ (5,515) | $ (44,707) | $ (94,007) | $ (49,936) |